{"title":"Industry","description":"","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-k113008-kodama-intravascular-ulrasound-catheter","title":"FDA 510(k), K113008, KODAMA INTRAVASCULAR ULRASOUND CATHETER","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K113008\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e KODAMA INTRAVASCULAR ULRASOUND CATHETER\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e SILICON VALLY MEDICAL INSTRUMENTS, INC.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e catheter, ultrasound, intravascular\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 870.1200\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e OBJ\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 10\/07\/2011\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 06\/14\/2012\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Cardiovascular","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069289517220,"sku":"FDA510K113008","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k102599-tomophase-octis","title":"FDA 510(k), K102599, TOMOPHASE OCTIS","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K102599\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e TOMOPHASE OCTIS\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e TOMOPHASE CORPORATION\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e system, imaging, optical coherence tomography (oct)\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 892.1560\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e NQQ\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 09\/10\/2010\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 12\/01\/2010\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Radiology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069289549988,"sku":"FDA510K102599","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k112997-hd-ivus-ultrasound-imaging-system","title":"FDA 510(k), K112997, HD-IVUS ULTRASOUND IMAGING SYSTEM","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K112997\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e HD-IVUS ULTRASOUND IMAGING SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e SILICON VALLY MEDICAL INSTRUMENTS, INC.\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 10\/07\/2011\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 12\/17\/2011\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Radiology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069289582756,"sku":"FDA510K112997","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k072652-enteral-feeding-spike-adapter","title":"FDA 510(k), K072652, ENTERAL FEEDING SPIKE ADAPTER","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K072652\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e ENTERAL FEEDING SPIKE ADAPTER\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e CEDIC S.R.L.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e tubes, gastrointestinal (and accessories)\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 876.5980\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e KNT\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 09\/20\/2007\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 01\/18\/2008\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Gastroenterology\/Urology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069289615524,"sku":"FDA510K072652","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k123765-guidezilla-guide-extension-catheter","title":"FDA 510(k), K123765, GUIDEZILLA GUIDE EXTENSION CATHETER","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K123765\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e GUIDEZILLA GUIDE EXTENSION CATHETER\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e BOSTON SCIENTIFIC\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e catheter, percutaneous\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 870.1250\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e DQY\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 12\/07\/2012\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 03\/19\/2013\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Cardiovascular","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069289648292,"sku":"FDA510K123765","price":89.0,"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)","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}]},{"product_id":"fda-510k-k123215-viscostat-clear","title":"FDA 510(k), K123215, VISCOSTAT CLEAR","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 KAREN KAKUNES \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}]},{"product_id":"fda-510k-k132790-infix-anterior-lumbar-system","title":"FDA 510(k), K132790, INFIX ANTERIOR LUMBAR SYSTEM","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K132790\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e INFIX ANTERIOR LUMBAR SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e ZIMMER SPINE, INC\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e intervertebral fusion device with bone graft, lumbar\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 888.3080\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e MAX\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 09\/06\/2013\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 12\/20\/2013\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Orthopedic","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069289877668,"sku":"FDA510K132790","price":89.0,"currency_code":"USD","in_stock":true}]},{"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","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}]},{"product_id":"fda-510k-k103477-permobil-m300-m400","title":"FDA 510(k), K103477, PERMOBIL M300 \/ M400","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}]},{"product_id":"fda-510k-k112514-apnea-risk-evaluation-system-ares","title":"FDA 510(k), K112514, APNEA RISK EVALUATION SYSTEM (ARES)","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K112514\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e APNEA RISK EVALUATION SYSTEM (ARES)\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e ADVANCED BRAIN MONITORING, INC.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e ventilatory effort recorder\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 868.2375\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e MNR\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 08\/30\/2011\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 01\/09\/2012\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Anesthesiology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069289975972,"sku":"FDA510K112514","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k140306-cormatrix-protect-ecm-envelope","title":"FDA 510(k), K140306, CORMATRIX PROTECT ECM ENVELOPE","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K140306\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e CORMATRIX PROTECT ECM ENVELOPE\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e CORMATRIX CARDIOVASCULAR, INC.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e mesh, surgical\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 878.3300\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e FTM\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 02\/07\/2014\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 08\/15\/2014\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e General \u0026amp; Plastic Surgery","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069290008740,"sku":"FDA510K140306","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k093548-avie-a1c-test-system","title":"FDA 510(k), K093548, AVIE A1C TEST SYSTEM","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K093548\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e AVIE A1C TEST SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e MEC DYNAMICS CORP\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e assay, glycosylated hemoglobin\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 864.7470\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e LCP\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 11\/17\/2009\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 07\/20\/2011\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Hematology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069290041508,"sku":"FDA510K093548","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k133718-zerona","title":"FDA 510(k), K133718, ZERONA","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K133718\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e ZERONA\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e ERCHONIA CORPORATION\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e fat reducing low level laser\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 878.5400\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e OLI\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 12\/04\/2013\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 05\/12\/2014\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e General \u0026amp; Plastic Surgery","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069290533028,"sku":"FDA510K133718","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k092264-atlantis-hyperbaric-chamber-ventilator","title":"FDA 510(k), K092264, ATLANTIS HYPERBARIC CHAMBER VENTILATOR","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K092264\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e ATLANTIS HYPERBARIC CHAMBER VENTILATOR\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e PROVIDENCE GLOBAL MEDICAL, 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 07\/28\/2009\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 12\/17\/2009\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Anesthesiology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069290598564,"sku":"FDA510K092264","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k021932-synthes-6-5-mm-cannulated-screw","title":"FDA 510(k), K021932, SYNTHES 6.5 MM CANNULATED SCREW","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K021932\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e SYNTHES 6.5 MM CANNULATED SCREW\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e SYNTHES (USA)\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e screw, fixation, bone\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 888.3040\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e HWC\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 06\/12\/2002\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 09\/06\/2002\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Orthopedic","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069290631332,"sku":"FDA510K021932","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k051296-sijf-cannulated-screw-system","title":"FDA 510(k), K051296, SIJF CANNULATED SCREW SYSTEM","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K051296\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e SIJF CANNULATED SCREW SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e DEPUY SPINE, INC.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e sacroiliac joint fixation\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 888.3040\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e OUR\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 05\/18\/2005\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 08\/26\/2005\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Orthopedic","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069290664100,"sku":"FDA510K051296","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k080398-si-joint-fusion-system","title":"FDA 510(k), K080398, SI JOINT FUSION SYSTEM","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K080398\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e SI JOINT FUSION SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e SI-BONE, INC.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e sacroiliac joint fixation\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 888.3040\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e OUR\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 02\/13\/2008\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 11\/26\/2008\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Orthopedic","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069290696868,"sku":"FDA510K080398","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k083415-peak-plasmablade-tna-tonsil-and-adenoid-tissue-dissection-device","title":"FDA 510(k), K083415, PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K083415\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e PEAK SURGICAL, INC.\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 11\/18\/2008\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 06\/05\/2009\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e General \u0026amp; Plastic Surgery","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069290762404,"sku":"FDA510K083415","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k073057-pulsar-generator-model-ps100-100-and-peak-plasmablade-tissue-dissection-device-model-ps200-040","title":"FDA 510(k), K073057, PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K073057\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e PEAK SURGICAL, INC.\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 10\/30\/2007\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 07\/22\/2008\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e General \u0026amp; Plastic Surgery","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069290827940,"sku":"FDA510K073057","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k123633-trs-cranial-bone-void-fillertrs-c-bvf","title":"FDA 510(k), K123633, TRS CRANIAL BONE VOID FILLER(TRS C-BVF)","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K123633\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e TRS CRANIAL BONE VOID FILLER(TRS C-BVF)\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e TISSUE REGENERATION SYSTEMS, INC.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e cover, burr hole\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 882.5250\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e GXR\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 11\/23\/2012\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 08\/16\/2013\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Neurology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069290893476,"sku":"FDA510K123633","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k092710-pentax-ed-3490tk-video-duodenoscope","title":"FDA 510(k), K092710, PENTAX ED-3490TK, VIDEO DUODENOSCOPE","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K092710\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e PENTAX ED-3490TK, VIDEO DUODENOSCOPE\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e PENTAX MEDICAL COMPANY\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e duodenoscope and accessories, flexible\/rigid\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 876.1500\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e FDT\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 09\/03\/2009\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 12\/02\/2009\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Gastroenterology\/Urology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069290926244,"sku":"FDA510K092710","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k140366-endlessfiber-reusable-surgical-laser-fiber","title":"FDA 510(k), K140366, ENDLESSFIBER REUSABLE SURGICAL LASER FIBER","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K140366\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e ENDLESSFIBER REUSABLE SURGICAL LASER FIBER\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e HOGUE SURGICAL LLC\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e powered laser surgical instrument\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 878.4810\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e GEX\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 02\/14\/2014\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 08\/15\/2014\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e General \u0026amp; Plastic Surgery","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069290959012,"sku":"FDA510K140366","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k151632-symphony-breastpump-symphony-reconditioned-symphony-preemie-breastpump-symphony-plus-breastpump-battery-version-symphony-consignment-preemie-consignment-pump-symphony-rental-symphony-plus-rental-symphony-preemie-rental","title":"FDA 510(k), K151632, Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K151632\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e MEDELA AG\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e pump, breast, powered\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 884.5160\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e HGX\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 06\/17\/2015\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 11\/05\/2015\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Obstetrics\/Gynecology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069290991780,"sku":"FDA510K151632","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k140459-altrus-thermal-tissue-fusion-energy-source-altrus-thermal-tissue-fusion-handpiece-altrus-thermal-tissue-fusion-system","title":"FDA 510(k), K140459, ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K140459\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e CONMED CORPORATION\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 02\/24\/2014\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 07\/11\/2014\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e General \u0026amp; Plastic Surgery","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069291057316,"sku":"FDA510K140459","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k124029-microline-flexible-ligating-shears","title":"FDA 510(k), K124029, MICROLINE FLEXIBLE LIGATING SHEARS","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K124029\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e MICROLINE FLEXIBLE LIGATING SHEARS\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e MICROLINE SURGICAL, INC\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 12\/28\/2012\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 03\/27\/2013\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e General \u0026amp; Plastic Surgery","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069291122852,"sku":"FDA510K124029","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k121891-newport-aura-ventilator","title":"FDA 510(k), K121891, NEWPORT AURA VENTILATOR","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K121891\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e NEWPORT AURA VENTILATOR\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e NEWPORT MEDICAL INSTRUMENTS, 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 06\/29\/2012\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 11\/09\/2012\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Anesthesiology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069291155620,"sku":"FDA510K121891","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k103008-inzone-detachment-system","title":"FDA 510(k), K103008, INZONE DETACHMENT SYSTEM","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K103008\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e INZONE DETACHMENT SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e BOSTON SCIENTIFIC CORP.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e device, neurovascular embolization\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 882.5950\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e HCG\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 10\/12\/2010\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 12\/10\/2010\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Neurology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069291188388,"sku":"FDA510K103008","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k942530-art-assist-model-aa-1000","title":"FDA 510(k), K942530, ART-ASSIST MODEL AA-1000","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K942530\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e ART-ASSIST MODEL AA-1000\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e ACI MEDICAL, INC.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e sleeve, limb, compressible\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 870.5800\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e JOW\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 05\/27\/1994\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 02\/28\/1996\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Cardiovascular","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069291221156,"sku":"FDA510K942530","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k131146-artassist-and-venassist","title":"FDA 510(k), K131146, ARTASSIST AND VENASSIST","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K131146\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e ARTASSIST AND VENASSIST\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e ACI MEDICAL, LLC\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e sleeve, limb, compressible\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 870.5800\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e JOW\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 04\/23\/2013\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 02\/10\/2014\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Cardiovascular","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069291286692,"sku":"FDA510K131146","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k072134-schick-computed-oral-radiology-system","title":"FDA 510(k), K072134, SCHICK COMPUTED ORAL RADIOLOGY SYSTEM","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K072134\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e SCHICK COMPUTED ORAL RADIOLOGY SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e SCHICK TECHNOLOGIES, INC.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e system, x-ray, extraoral source, digital\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 872.1800\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e MUH\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 08\/02\/2007\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 11\/02\/2007\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Dental","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069291417764,"sku":"FDA510K072134","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k093642-neutrasal","title":"FDA 510(k), K093642, NEUTRASAL","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K093642\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e NEUTRASAL\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e INVADO PHARMACEUTICALS\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e saliva, artificial\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e \n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e LFD\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 11\/24\/2009\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 12\/11\/2009\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e ","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069291450532,"sku":"FDA510K093642","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k070598-memometal-intra-medullary-bone-fastener-models-smart-toe-x-fuse","title":"FDA 510(k), K070598, MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE \/ X-FUSE","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K070598\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE \/ X-FUSE\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e MEMOMETAL TECHNOLOGIES\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e pin, fixation, smooth\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 888.3040\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e HTY\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 03\/02\/2007\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 07\/26\/2007\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Orthopedic","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069291679908,"sku":"FDA510K070598","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k092239-rosa-surgical-device-model-rosa-1-1","title":"FDA 510(k), K092239, ROSA SURGICAL DEVICE, MODEL ROSA 1.1","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K092239\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e ROSA SURGICAL DEVICE, MODEL ROSA 1.1\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e MEDTECH S.A.\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\/23\/2009\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 11\/17\/2009\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Neurology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069291712676,"sku":"FDA510K092239","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k123421-olympus-small-intestinal-capsule-endoscope-system","title":"FDA 510(k), K123421, OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K123421\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e OLYMPUS MEDICAL SYSTEMS CORP.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e system, imaging, gastrointestinal, wireless, capsule\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 876.1300\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e NEZ\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 11\/06\/2012\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 04\/29\/2013\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Gastroenterology\/Urology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069291810980,"sku":"FDA510K123421","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k083580-anti-wrinkle-light-model-1302-and-pain-therapy-light-model-1301","title":"FDA 510(k), K083580, ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K083580\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e LED INTELLECTUAL PROPERTIES, LLC\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e lamp, infrared, therapeutic heating\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 890.5500\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e ILY\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 12\/03\/2008\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 06\/22\/2009\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Physical Medicine","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069291876516,"sku":"FDA510K083580","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k090042-painmaster-mct-patch","title":"FDA 510(k), K090042, PAINMASTER MCT PATCH","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K090042\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e PAINMASTER MCT PATCH\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e NEWMARK, INC.\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\/06\/2009\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 05\/06\/2009\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Neurology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069291909284,"sku":"FDA510K090042","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k120500-the-pain-pilot-a-k-a-pain-pilot","title":"FDA 510(k), K120500, THE PAIN PILOT (A.K.A PAIN PILOT)","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K120500\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e THE PAIN PILOT (A.K.A PAIN PILOT)\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e HOLLYWOG, 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 02\/21\/2012\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 08\/20\/2012\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Neurology","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069292007588,"sku":"FDA510K120500","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k123229-remote-presence-system-model-rp-vita","title":"FDA 510(k), K123229, REMOTE PRESENCE SYSTEM, MODEL RP-VITA","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K123229\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e REMOTE PRESENCE SYSTEM, MODEL RP-VITA\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e INTOUCH HEALTH, INC.\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e transmitters and receivers, physiological signal, radiofrequency\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 870.2910\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e DRG\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 10\/15\/2012\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 11\/20\/2012\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Cardiovascular","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069292040356,"sku":"FDA510K123229","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k141389-sapphire-infusion-pump","title":"FDA 510(k), K141389, SAPPHIRE INFUSION PUMP","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}]},{"product_id":"fda-510k-k141102-hospira-mednet-medication-management-suite","title":"FDA 510(k), K141102, HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K141102\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e HOSPIRA, INC.\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 04\/29\/2014\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 07\/08\/2014\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e General Hospital","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069292105892,"sku":"FDA510K141102","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k141825-ideal-locking-plate-system","title":"FDA 510(k), K141825, IDEAL Locking Plate System","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K141825\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e IDEAL Locking Plate System\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e JIANGSU IDEAL MEDICAL SCIENCE \u0026amp; TECHNOLOGY CO., LT\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\/07\/2014\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 03\/03\/2015\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Orthopedic","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069292138660,"sku":"FDA510K141825","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k142418-i-t-s-hand-locking-plates-system-hls","title":"FDA 510(k), K142418, I.T.S. Hand Locking Plates System - HLS","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K142418\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e I.T.S. Hand Locking Plates System - HLS\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e I.T.S. GmbH\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 08\/28\/2014\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 09\/26\/2014\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Orthopedic","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069292171428,"sku":"FDA510K142418","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k150009-baide","title":"FDA 510(k), K150009, Baide","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K150009\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e Baide\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Jiangsu Baide Medical Intrument Co.,Ltd.\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 01\/02\/2015\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 02\/25\/2015\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Orthopedic","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069292269732,"sku":"FDA510K150009","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k070793-sbi-distal-radius-volar-plating-system","title":"FDA 510(k), K070793, SBI DISTAL RADIUS VOLAR PLATING SYSTEM","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K070793\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e SBI DISTAL RADIUS VOLAR PLATING SYSTEM\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e SMALL BONE INNOVATIONS 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 03\/22\/2007\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 05\/30\/2007\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Orthopedic","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069292335268,"sku":"FDA510K070793","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k131287-cardiosleeve","title":"FDA 510(k), K131287, CARDIOSLEEVE","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K131287\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e CARDIOSLEEVE\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e RIJUVEN CORP\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e stethoscope, electronic\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 870.1875\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e DQD\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 05\/06\/2013\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 06\/24\/2013\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Cardiovascular","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069292368036,"sku":"FDA510K131287","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k141139-solex-intravascular-heat-exchange-catheter","title":"FDA 510(k), K141139, SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K141139\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e ZOLL CIRCULATION\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e system, hypothermia, intravenous, cooling\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 870.5900\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e NCX\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 05\/02\/2014\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 10\/03\/2014\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Cardiovascular","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069292400804,"sku":"FDA510K141139","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k142024-brightmatter-navigation-system","title":"FDA 510(k), K142024, BRIGHTMATTER NAVIGATION SYSTEM","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}]},{"product_id":"fda-510k-k130978-ztx-ultrasonic-diathermy-device","title":"FDA 510(k), K130978, ZTX ULTRASONIC DIATHERMY DEVICE","description":"\u003cb\u003e510(K) Number:\u003c\/b\u003e K130978\n\u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e ZTX ULTRASONIC DIATHERMY DEVICE\n\u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e ZetrOZ INC\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e stationary ultrasonic diathermy device for use in applying therapeutic deep heat\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 890.5300\n\u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e PFW\n\u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 04\/09\/2013\n\u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 11\/06\/2013\n\u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Physical Medicine","brand":"FDA","offers":[{"title":"Default Title","offer_id":46069292499108,"sku":"FDA510K130978","price":89.0,"currency_code":"USD","in_stock":true}]}],"url":"https:\/\/foiadocs.com\/collections\/industry.oembed?page=87","provider":"FOIA Document Source","version":"1.0","type":"link"}