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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}]},{"product_id":"fda-510k-k132403-annextm-adjacent-level-system","title":"FDA 510(k), K132403, ANNEXTM ADJACENT LEVEL SYSTEM","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}]},{"product_id":"fda-510k-k050418-tissue-fixation-system","title":"FDA 510(k), K050418, TISSUE FIXATION SYSTEM","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}]},{"product_id":"fda-510k-k141081-filtek-bulk-fill-posterior-restroative","title":"FDA 510(k), K141081, FILTEK BULK FILL POSTERIOR RESTROATIVE","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 SCOTT ERICKSON\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}]},{"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)","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 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Title","offer_id":46069302001828,"sku":"FDA510K103110","price":89.0,"currency_code":"USD","in_stock":true}]},{"product_id":"fda-510k-k131198-tipi-otc","title":"FDA 510(k), K131198, TIPI OTC","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}]},{"product_id":"fda-510k-k142327-smartrack-feeding-tube-system","title":"FDA 510(k), K142327, smARTrack Feeding Tube System","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}]},{"product_id":"fda-510k-k130921-alivecor-heart-monitor-otc","title":"FDA 510(k), K130921, ALIVECOR HEART MONITOR OTC","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 MICHAEL RIGHTER\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 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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}]},{"product_id":"fda-510k-k141518-nellcor-bedside-respiratory-patient-monitoring-system","title":"FDA 510(k), K141518, Nellcor Bedside Respiratory Patient Monitoring System","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}]},{"product_id":"fda-510k-k143700-cpap-cannulaide","title":"FDA 510(k), K143700, CPAP Cannulaide","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}]},{"product_id":"fda-510k-k141943-breathe-technologies-life2000-ventilation-system","title":"FDA 510(k), K141943, BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM","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 Samir Ahmad\n\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e Ventilator, Continuous, Facility Use\n\u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 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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}]},{"product_id":"fda-510k-k152525-tr-band-radial-compression-device","title":"FDA 510(k), K152525, TR BAND Radial Compression Device","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 LIANG LU\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}]},{"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","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}]},{"product_id":"fda-510k-k110943-logiq-e9","title":"FDA 510(k), K110943, LOGIQ E9","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}]},{"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","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}]}],"url":"https:\/\/foiadocs.com\/collections\/industry.oembed?page=136","provider":"FOIA Document Source","version":"1.0","type":"link"}