{"title":"Available Now","description":"\u003cp\u003eAvailable for immediate download. \u003c\/p\u003e","products":[{"product_id":"1002-fda-approval-bla-125062-674","title":"1002FDAA2405: FDA Approval BLA 125062\/674","description":"\u003cp\u003e\u003ca data-sheets-formula-bar-text-style=\"font-size:13px;color:#1155cc;font-weight:normal;text-decoration:underline;font-family:'docs-Calibri';font-style:normal;text-decoration-skip-ink:none;\" class=\"waffle-rich-text-link\" data-sheets-formula-bar-text-link=\"https:\/\/drive.google.com\/drive\/u\/0\/folders\/1Qx78z5QdHq76C0WQCim2e7Lijp9lv9Ix\"\u003eSupplemental drug approval package for Octagam, BLA 125062\/674, approved 07\/15\/2021 for dermatomyositis\u003c\/a\u003e\u003c\/p\u003e\n\u003c!----\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":45836643238052,"sku":"1002FDAA2405","price":56.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k133338-ligasure-5-mm-maryland-jaw-sealer-divider-one-step-sealing-lf-17xx","title":"FDA 510(k) K133338, LIGASURE 5 MM MARYLAND JAW SEALER\/DIVIDER ONE-STEP SEALING (LF 17XX), by Covidien, Formerly Valleylab, A Division of Tyco H","description":"\u003cp\u003e\u003cb\u003e510(K) Number:\u003c\/b\u003e K133338 \u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e LIGASURE 5 MM MARYLAND JAW SEALER\/DIVIDER ONE-STEP SEALING (LF 17XX) \u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Covidien, Formerly Valleylab, A Division of Tyco H\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e electrosurgical, cutting \u0026amp; coagulation \u0026amp; accessories \u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 878.4400 \u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e GEI \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 10\/30\/2013 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 12\/20\/2013 \u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e General \u0026amp; Plastic Surgery\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069289681060,"sku":"FDA510K133338","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k123215-viscostat-clear","title":"FDA 510(k) K123215, VISCOSTAT CLEAR, by Ultradent Products, Inc.","description":"\u003cp\u003e\u003cb\u003e510(K) Number:\u003c\/b\u003e K123215 \u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e VISCOSTAT CLEAR \u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Ultradent Products, Inc.\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e Cord, Retraction \u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e MVL \u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e KXA \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 10\/15\/2012 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 02\/05\/2013 \u003cbr\u003e\u003cb\u003eDecision:\u003c\/b\u003e Substantially Equivalent (SESE) \u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Dental\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069289844900,"sku":"FDA510K123215","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k130738-endoscopic-linear-cutting-staplers-with-single-use-loading-units","title":"FDA 510(k) K130738, ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS, by Nanjing Maidixin Medical Device Co., Ltd.","description":"\u003cp\u003e\u003cb\u003e510(K) Number:\u003c\/b\u003e K130738 \u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS \u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Nanjing Maidixin Medical Device Co., Ltd.\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e staple, implantable \u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 878.4750 \u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e GDW \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 03\/18\/2013 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 12\/13\/2013 \u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e General \u0026amp; Plastic Surgery\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069289910436,"sku":"FDA510K130738","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k103477-permobil-m300-m400","title":"FDA 510(k) K103477, PERMOBIL M300 \/ M400, by Permobil AB","description":"\u003cp\u003e\u003cb\u003e510(K) Number:\u003c\/b\u003e K103477 \u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e PERMOBIL M300 \/ M400 \u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Permobil AB\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e wheelchair, powered \u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 890.3860 \u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e ITI \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 11\/26\/2010 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 03\/03\/2011 \u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Physical Medicine\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069289943204,"sku":"FDA510K103477","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k141389-sapphire-infusion-pump","title":"FDA 510(k) K141389, SAPPHIRE INFUSION PUMP, by Q Core Medical , Ltd.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K141389\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e SAPPHIRE INFUSION PUMP\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Q Core Medical , Ltd.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e pump, infusion\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 880.5725\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e FRN\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 05\/27\/2014\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 12\/11\/2014\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e General Hospital","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069292073124,"sku":"FDA510K141389","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k142024-brightmatter-navigation-system","title":"FDA 510(k) K142024, BRIGHTMATTER NAVIGATION SYSTEM, by Synaptive Medical, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K142024\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e BRIGHTMATTER NAVIGATION SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Synaptive Medical, Inc.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e neurological stereotaxic instrument\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 882.4560\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e HAW\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 07\/25\/2014\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 04\/02\/2015\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Neurology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069292466340,"sku":"FDA510K142024","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k131973-unexef-38g-ultrasound-system","title":"FDA 510(k) K131973, UNEXEF-38G ULTRASOUND SYSTEM, by Toyota Tsusho Corporation","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K131973\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e UNEXEF-38G ULTRASOUND SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Toyota Tsusho Corporation\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e system, imaging, pulsed doppler, ultrasonic\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 892.1550\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e IYN\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 06\/28\/2013\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 11\/18\/2014\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Radiology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069292564644,"sku":"FDA510K131973","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k140575-engstrom-carestation-engstrom-pro","title":"FDA 510(k) K140575, ENGSTROM CARESTATION, ENGSTROM PRO, by Datex-Ohmeda, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K140575\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e ENGSTROM CARESTATION, ENGSTROM PRO\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Datex-Ohmeda, Inc.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e Ventilator, Continuous, Facility Use\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e CBK\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e KXA \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 03\/06\/2014 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 02\/03\/2015\n\u003cbr\u003e\u003cb\u003eDecision:\u003c\/b\u003e Substantially Equivalent (SESE)\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Anesthesiology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069292794020,"sku":"FDA510K140575","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k142973-resolution-clip","title":"FDA 510(k) K142973, Resolution Clip, by Boston Scientific Corporation","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K142973\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e Resolution Clip\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Boston Scientific Corporation\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e hemostatic metal clip for the gi tract\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 876.4400\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e PKL\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 10\/14\/2014\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 12\/01\/2014\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Gastroenterology\/Urology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069298987172,"sku":"FDA510K142973","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k141399-freedom-spinal-cord-stimulator-scs-system","title":"FDA 510(k) K141399, FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM, by Stimwave Technologies Incorporated","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K141399\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Stimwave Technologies Incorporated\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e stimulator, spinal-cord, implanted (pain relief)\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 882.5880\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e GZB\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 05\/28\/2014\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 10\/10\/2014\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Neurology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069299347620,"sku":"FDA510K141399","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k010315-iscreen-vision-screener","title":"FDA 510(k) K010315, ISCREEN VISION SCREENER, by Iscreen, LLC","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K010315\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e ISCREEN VISION SCREENER\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Iscreen, LLC\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e camera, ophthalmic, ac-powered\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 886.1120\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e HKI\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 02\/02\/2001\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 06\/01\/2001\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Ophthalmic","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069300363428,"sku":"FDA510K010315","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k133237-gel-bead-embolization-spheres","title":"FDA 510(k) K133237, GEL-BEAD EMBOLIZATION SPHERES, by Vascular Solutions, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K133237\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e GEL-BEAD EMBOLIZATION SPHERES\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Vascular Solutions, Inc.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e Device, Vascular, For Promoting Embolization\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e KRD\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e KXA \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 10\/21\/2013 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 04\/25\/2014\n\u003cbr\u003e\u003cb\u003eDecision:\u003c\/b\u003e Substantially Equivalent (SESE)\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Cardiovascular","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069300396196,"sku":"FDA510K133237","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k141288-voyant-electrosurgical-generator-voyant-5mm-laparoscopic-sealer-divider-device","title":"FDA 510(k) K141288, VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE, by Applied Medical Resources","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K141288\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Applied Medical Resources\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e electrosurgical, cutting \u0026amp; coagulation \u0026amp; accessories\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 878.4400\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e GEI\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 05\/16\/2014\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 08\/22\/2014\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e General \u0026amp; Plastic Surgery","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069300428964,"sku":"FDA510K141288","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k112174-ncb-periprosthetic-femur-polyaxial-locking-plate-system","title":"FDA 510(k) K112174, NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM, by Zimmer, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K112174\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Zimmer, Inc.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e plate, fixation, bone\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 888.3030\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e HRS\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 07\/28\/2011\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 10\/26\/2011\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Orthopedic","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069300854948,"sku":"FDA510K112174","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k132733-orthohelix-syndesmosis-fixation-devices","title":"FDA 510(k) K132733, ORTHOHELIX SYNDESMOSIS FIXATION DEVICES, by Orthohelix Surgical Designs, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K132733\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e ORTHOHELIX SYNDESMOSIS FIXATION DEVICES\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Orthohelix Surgical Designs, Inc.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e washer, bolt nut\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 888.3030\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e HTN\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 09\/03\/2013\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 01\/03\/2014\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Orthopedic","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069301051556,"sku":"FDA510K132733","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k141929-accu-chek-connect-diabetes-management-app","title":"FDA 510(k) K141929, ACCU-CHEK CONNECT DIABETES MANAGEMENT APP, by Roche Diagnostics Corporation","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K141929\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e ACCU-CHEK CONNECT DIABETES MANAGEMENT APP\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Roche Diagnostics Corporation\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e calculator, drug dose\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 868.1890\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e NDC\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 07\/16\/2014\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 03\/16\/2015\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Anesthesiology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069301215396,"sku":"FDA510K141929","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k132403-annextm-adjacent-level-system","title":"FDA 510(k) K132403, ANNEXTM ADJACENT LEVEL SYSTEM, by Spine Wave, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K132403\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e ANNEXTM ADJACENT LEVEL SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Spine Wave, Inc.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e orthosis, spondylolisthesis spinal fixation\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 888.3070\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e MNH\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 08\/01\/2013\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 01\/10\/2014\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Orthopedic","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069301313700,"sku":"FDA510K132403","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k050418-tissue-fixation-system","title":"FDA 510(k) K050418, TISSUE FIXATION SYSTEM, by Tfs Manufacturing Pty, Ltd.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K050418\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e TISSUE FIXATION SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Tfs Manufacturing Pty, Ltd.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e mesh, surgical, polymeric\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 878.3300\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e FTL\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 02\/18\/2005\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 05\/16\/2005\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e General \u0026amp; Plastic Surgery","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069301444772,"sku":"FDA510K050418","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k141081-filtek-bulk-fill-posterior-restroative","title":"FDA 510(k) K141081, FILTEK BULK FILL POSTERIOR RESTROATIVE, by 3M Espe Dental Products","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K141081\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e FILTEK BULK FILL POSTERIOR RESTROATIVE\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e 3M Espe Dental Products\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e Material, Tooth Shade, Resin\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e EBF\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e KXA \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 04\/25\/2014 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 05\/08\/2014\n\u003cbr\u003e\u003cb\u003eDecision:\u003c\/b\u003e Substantially Equivalent (SESE)\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Dental","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069301477540,"sku":"FDA510K141081","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k113088-hummingbird-subdural-h900ds-drainage-and-icp-hummingbird-subdural-h800s-icp-only","title":"FDA 510(k) K113088, HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY), by Innerspace, Inc.","description":"\u003cp\u003e\u003cb\u003e510(K) Number:\u003c\/b\u003e K113088 \u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) \u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Innerspace, Inc.\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e device, monitoring, intracranial pressure \u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 882.1620 \u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e GWM \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 10\/19\/2011 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 05\/02\/2012 \u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Neurology\u003c\/p\u003e\n\u003cp\u003e\u003cmeta charset=\"utf-8\"\u003eTotal pages: 148\u003cbr data-start=\"16\" data-end=\"19\"\u003eFully redacted pages: 30\u003cbr data-start=\"43\" data-end=\"46\"\u003eContent pages: 118\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069301608612,"sku":"FDA510K113088","price":322.33,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k131198-tipi-otc","title":"FDA 510(k) K131198, TIPI OTC, by Contipi , Ltd.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K131198\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e TIPI OTC\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Contipi , Ltd.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e pessary, vaginal\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 884.3575\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e HHW\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 04\/26\/2013\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 08\/27\/2013\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Obstetrics\/Gynecology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069303312548,"sku":"FDA510K131198","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k142327-smartrack-feeding-tube-system","title":"FDA 510(k) K142327, smARTrack Feeding Tube System, by Art Healthcare , Ltd.","description":"\u003cp\u003e\u003cb\u003e510(K) Number:\u003c\/b\u003e K142327 \u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e smARTrack Feeding Tube System \u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Art Healthcare , Ltd.\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e tubes, gastrointestinal (and accessories) \u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 876.5980 \u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e KNT \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 08\/20\/2014 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 06\/08\/2015 \u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Gastroenterology\/Urology\u003c\/p\u003e\n\u003cp\u003e\u003cmeta charset=\"utf-8\"\u003eTotal pages: 1499\u003cbr data-start=\"67\" data-end=\"70\"\u003eFully redacted pages: 1361\u003cbr data-start=\"96\" data-end=\"99\"\u003eContent pages: 138\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069303410852,"sku":"FDA510K142327","price":392.19,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k130921-alivecor-heart-monitor-otc","title":"FDA 510(k) K130921, ALIVECOR HEART MONITOR OTC, by AliveCor, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K130921\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e ALIVECOR HEART MONITOR OTC\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e AliveCor, Inc.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e Electrocardiograph\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e DPS\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e KXA \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 04\/03\/2013 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 02\/06\/2014\n\u003cbr\u003e\u003cb\u003eDecision:\u003c\/b\u003e Substantially Equivalent (SESE)\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Cardiovascular","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069303476388,"sku":"FDA510K130921","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k143275-iolmaster700","title":"FDA 510(k) K143275, IOLMaster700, by Carl Zeiss Meditec, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K143275\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e IOLMaster700\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Carl Zeiss Meditec, Inc.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e biomicroscope, slit-lamp, ac-powered\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 886.1850\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e HJO\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 11\/14\/2014\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 07\/10\/2015\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Ophthalmic","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069303607460,"sku":"FDA510K143275","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k141518-nellcor-bedside-respiratory-patient-monitoring-system","title":"FDA 510(k) K141518, Nellcor Bedside Respiratory Patient Monitoring System, by Covidien","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K141518\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e Nellcor Bedside Respiratory Patient Monitoring System\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Covidien\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e oximeter\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 870.2700\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e DQA\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 06\/09\/2014\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 03\/05\/2015\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Cardiovascular","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069304328356,"sku":"FDA510K141518","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k143700-cpap-cannulaide","title":"FDA 510(k) K143700, CPAP Cannulaide, by Salter Labs","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K143700\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e CPAP Cannulaide\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Salter Labs\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e ventilator, non-continuous (respirator)\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 868.5905\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e BZD\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 12\/24\/2014\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 08\/05\/2015\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Anesthesiology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069304492196,"sku":"FDA510K143700","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k141943-breathe-technologies-life2000-ventilation-system","title":"FDA 510(k) K141943, BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM, by Breathe Technologies","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K141943\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Breathe Technologies\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e Ventilator, Continuous, Facility Use\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e CBK\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e KXA \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 07\/17\/2014 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 06\/12\/2015\n\u003cbr\u003e\u003cb\u003eDecision:\u003c\/b\u003e Substantially Equivalent (SESE)\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Anesthesiology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069304557732,"sku":"FDA510K141943","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k150638-af541-se-full-face-mask","title":"FDA 510(k) K150638, AF541 SE Full Face Mask, by Respironics, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K150638\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e AF541 SE Full Face Mask\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Respironics, Inc.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e ventilator, continuous, facility use\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 868.5895\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e CBK\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 03\/11\/2015\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 09\/18\/2015\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Anesthesiology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069304623268,"sku":"FDA510K150638","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k150572-respire-pink-series-herbst-ef","title":"FDA 510(k) K150572, Respire Pink Series-Herbst-EF, by Respire Medical Holding","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K150572\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e Respire Pink Series-Herbst-EF\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Respire Medical Holding\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e device, anti-snoring\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 872.5570\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e LRK\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 03\/06\/2015\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 08\/27\/2015\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Dental","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069304787108,"sku":"FDA510K150572","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k100116-lasertouchone-otc","title":"FDA 510(k) K100116, LASERTOUCHONE (OTC), by Laser Health Technologies, LLC","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K100116\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e LASERTOUCHONE (OTC)\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Laser Health Technologies, LLC\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e stimulator, nerve, transcutaneous, over-the-counter\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 882.5890\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e NUH\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 01\/15\/2010\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 04\/15\/2010\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Neurology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069304918180,"sku":"FDA510K100116","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k140497-ecvue-mapping-system","title":"FDA 510(k) K140497, ECVUE MAPPING SYSTEM, by Cardioinsight Technologies, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K140497\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e ECVUE MAPPING SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Cardioinsight Technologies, Inc.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e computer, diagnostic, programmable\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 870.1425\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e DQK\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 02\/27\/2014\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 11\/19\/2014\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Cardiovascular","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069305409700,"sku":"FDA510K140497","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k151623-penumbra-system-110-aspiration-tubing","title":"FDA 510(k) K151623, Penumbra System 110 Aspiration Tubing, by Penumbra, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K151623\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e Penumbra System 110 Aspiration Tubing\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Penumbra, Inc.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e catheter, thrombus retriever\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 870.1250\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e NRY\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 06\/16\/2015\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 08\/06\/2015\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Cardiovascular","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069305573540,"sku":"FDA510K151623","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k160449-penumbra-system-penumbra-pump-max","title":"FDA 510(k) K160449, Penumbra System, Penumbra Pump MAX, by Penumbra, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K160449\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e Penumbra System, Penumbra Pump MAX\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Penumbra, Inc.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e Catheter, Thrombus Retriever\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e NRY\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e KXA \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 02\/18\/2016 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 05\/25\/2016\n\u003cbr\u003e\u003cb\u003eDecision:\u003c\/b\u003e Substantially Equivalent (SESE)\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Neurology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069305639076,"sku":"FDA510K160449","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k161640-penumbra-system-ace-68-reperfusion-catheter","title":"FDA 510(k) K161640, Penumbra System ACE 68 Reperfusion Catheter, by Penumbra, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K161640\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e Penumbra System ACE 68 Reperfusion Catheter\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Penumbra, Inc.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e catheter, thrombus retriever\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 870.1250\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e NRY\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 06\/14\/2016\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 07\/12\/2016\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Cardiovascular","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069305671844,"sku":"FDA510K161640","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k981973-safe-t-fill-capillary-blood-collection-system","title":"FDA 510(k) K981973, SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM, by Ram Scientific","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K981973\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Ram Scientific\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e tubes, vials, systems, serum separators, blood collection\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 862.1675\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e JKA\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 06\/05\/1998\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 09\/03\/1998\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Clinical Chemistry","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069305966756,"sku":"FDA510K981973","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k141745-iqqa-bodyimaging-software","title":"FDA 510(k) K141745, IQQA-BODYIMAGING SOFTWARE, by Edda Technology","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K141745\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e IQQA-BODYIMAGING SOFTWARE\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Edda Technology\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e system, image processing, radiological\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 892.2050\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e LLZ\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 06\/30\/2014\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 10\/31\/2014\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Radiology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069306720420,"sku":"FDA510K141745","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k151436-pico-single-use-negative-pressure-wound-therapy-system","title":"FDA 510(k) K151436, PICO Single Use Negative Pressure Wound Therapy System, by Smith \u0026 Nephew Medical, Ltd.","description":"\u003cp\u003e\u003cb\u003e510(K) Number:\u003c\/b\u003e K151436 \u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e PICO Single Use Negative Pressure Wound Therapy System \u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Smith \u0026amp; Nephew Medical, Ltd.\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e negative pressure wound therapy powered suction pump \u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 878.4780 \u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e OMP \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 05\/28\/2015 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 01\/28\/2016 \u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e General \u0026amp; Plastic Surgery\u003c\/p\u003e\n\u003cp\u003eTotal pages: 593\u003cbr\u003eFully redacted pages: 485\u003cbr\u003eContent pages: 108\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069306851492,"sku":"FDA510K151436","price":302.83,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k042515-smith-nephew-inc-high-performance-knee","title":"FDA 510(k) K042515, SMITH \u0026 NEPHEW, INC. HIGH PERFORMANCE KNEE, by Smith \u0026 Nephew, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K042515\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e SMITH \u0026amp; NEPHEW, INC. HIGH PERFORMANCE KNEE\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Smith \u0026amp; Nephew, Inc.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer\/metal\/polymer\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 888.3560\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e JWH\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 09\/16\/2004\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 03\/14\/2005\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Orthopedic","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069307211940,"sku":"FDA510K042515","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k140828-neuroreader-medical-image-processing-software","title":"FDA 510(k) K140828, NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE, by Brainreader Aps","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K140828\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Brainreader Aps\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e System, Image Processing, Radiological\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e LLZ\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e KXA \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 04\/01\/2014 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 02\/04\/2015\n\u003cbr\u003e\u003cb\u003eDecision:\u003c\/b\u003e Substantially Equivalent (SESE)\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Radiology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069307900068,"sku":"FDA510K140828","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k863547-medtronic-model-5455-disposable-surgical-cable","title":"FDA 510(k) K863547, MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE, by Medtronic Vascular","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K863547\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Medtronic Vascular\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e pacemaker, cardiac, external transcutaneous (non-invasive)\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 870.5550\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e DRO\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 09\/12\/1986\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 10\/31\/1986\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Cardiovascular","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069310619812,"sku":"FDA510K863547","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k803311-ll100-cryosurgical-system","title":"FDA 510(k) K803311, LL100 CRYOSURGICAL SYSTEM, by Wallach Surgical Devices, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K803311\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e LL100 CRYOSURGICAL SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Wallach Surgical Devices, Inc.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e unit, cryosurgical, accessories\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 878.4350\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e GEH\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 01\/02\/1981\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 02\/04\/1981\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e General \u0026amp; Plastic Surgery","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069311045796,"sku":"FDA510K803311","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k152033-cook-ecm-powder","title":"FDA 510(k) K152033, Cook ECM Powder, by Cook Biotech Incorporated","description":"\u003cp\u003e\u003cb\u003e510(K) Number:\u003c\/b\u003e K152033 \u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e Cook ECM Powder \u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Cook Biotech Incorporated\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e wound dressing with animal-derived material(s) \u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e \u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e KGN \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 07\/22\/2015 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 08\/19\/2015\u003cbr\u003e\u003c\/p\u003e\n\u003cp\u003eTotal pages: 182\u003cbr\u003eFully redacted pages: 79\u003cbr\u003eContent pages: 103\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069311111332,"sku":"FDA510K152033","price":302.83,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k150409-vivace-electrosurgical-system","title":"FDA 510(k) K150409, VIVACE Electrosurgical System, by Sung Hwan E\u0026B Co.,Ltd","description":"\u003cp\u003e\u003cb\u003e510(K) Number:\u003c\/b\u003e K150409 \u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e VIVACE Electrosurgical System \u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Sung Hwan E\u0026amp;B Co.,Ltd\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e skin resurfacing rf applicator \u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 878.4400 \u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e OUH \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 02\/18\/2015 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 01\/15\/2016 \u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e General \u0026amp; Plastic Surgery\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eNOTE:\u003c\/strong\u003e \u003cspan\u003e53 out of 99 pages fully redacted and most removed from the file.\u003c\/span\u003e\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069311471780,"sku":"FDA510K150409","price":153.34,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k152525-tr-band-radial-compression-device","title":"FDA 510(k) K152525, TR BAND Radial Compression Device, by Terumo Medical Corporation","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K152525\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e TR BAND Radial Compression Device\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Terumo Medical Corporation\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e Clamp, Vascular\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e DXC\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e KXA \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 09\/03\/2015 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 11\/10\/2015\n\u003cbr\u003e\u003cb\u003eDecision:\u003c\/b\u003e Substantially Equivalent (SESE)\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Cardiovascular","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069311570084,"sku":"FDA510K152525","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k082185-ge-logiq-e9-diagnostic-ultrasound-system-models-5205000-5205000-2","title":"FDA 510(k) K082185, GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2, by Ge Medical Systems Ultrasound and Primary Care Dia","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K082185\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Ge Medical Systems Ultrasound and Primary Care Dia\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e system, imaging, pulsed echo, ultrasonic\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 892.1560\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e IYO\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 08\/01\/2008\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 08\/15\/2008\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Radiology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069311799460,"sku":"FDA510K082185","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k110943-logiq-e9","title":"FDA 510(k) K110943, LOGIQ E9, by GE Healthcare","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K110943\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e LOGIQ E9\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e GE Healthcare\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e system, imaging, pulsed doppler, ultrasonic\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 892.1550\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e IYN\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 04\/04\/2011\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 07\/22\/2011\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Radiology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069311864996,"sku":"FDA510K110943","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k092271-ge-logiq-e9-bt2010-diagnostic-ultrasound-system-model-5205000-3-5205000-4","title":"FDA 510(k) K092271, GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4, by GE Healthcare","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K092271\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e GE Healthcare\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e system, imaging, pulsed doppler, ultrasonic\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 892.1550\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e IYN\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 07\/28\/2009\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 11\/17\/2009\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Radiology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069311897764,"sku":"FDA510K092271","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k141757-alere-i-strep-a","title":"FDA 510(k) K141757, ALERE I STREP A, by Alere Scarborough, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K141757\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e ALERE I STREP A\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Alere Scarborough, Inc.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e PGX\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e KXA \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 06\/30\/2014 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 03\/31\/2015\n\u003cbr\u003e\u003cb\u003eDecision:\u003c\/b\u003e Substantially Equivalent (SESE)\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Microbiology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069311930532,"sku":"FDA510K141757","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"},{"product_id":"fda-510k-k120151-nebulae-i","title":"FDA 510(k) K120151, NEBULAE I, by Northgate Technologies, Inc.","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K120151\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e NEBULAE I\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Northgate Technologies, Inc.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e insufflator, laparoscopic\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 884.1730\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e HIF\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 01\/18\/2012\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 08\/17\/2012\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Obstetrics\/Gynecology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069312323748,"sku":"FDA510K120151","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400"}],"url":"https:\/\/foiadocs.com\/collections\/available-now.oembed?page=81","provider":"FOIA Document Source","version":"1.0","type":"link"}