Atlas FDA

2016

2,564 FDA 510(k) clearances · PMA decision year

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◉ Watch 2016

RecordFirmDate
EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATORS (P790005/S054)Ahp Eos Buyer, Inc.2016-01-14
CAPSURE SP NOVUS LEAD; CAPSURE Z NOVUS LEAD; VITATRON EXCELLENCE SS+LEAD; VITATRON IMPULSE II LEAD (P850089/S115)Medtronic Cardiac Rhythm Disease Management2016-01-13
CAPSURE EPICARDIAL PACING LEAD (P950024/S066)Medtronic, Inc.2016-01-13
MYOCARDIAL PACING LEAD (P120017/S002)Medtronic, Inc.2016-01-13
ATTAIN STARFIX LEAD (P060039/S068)Medtronic, Inc.2016-01-13
CAPSURE VDD 2 LEAD; VITATRON BRILLIANT S+VDD LEAD;VITATRON BRILLAIANT S+VDD LEAD (P890003/S347)Medtronic, Inc.2016-01-13
EVERA MRI ,EVERA, MARQUIS, SECURA, MAXIMO II, INTRINSIC, PROTECTA, PROTECTA XT, VIRTUOSO (P980016/S560)Medtronic Cardiac Rhythm Disease Management2016-01-13
MEDTRONIC CARELINK HOME MONITOR 2490C (P890003/S343)Medtronic, Inc.2016-01-13
BRAVA, BRAVA QUAD, CONCERTO, CONCERTO II, CONSULTA, MAXIMO II,PROTECTA, PROTECTA XT, VIVA QUAD, VIVA S, VIVA XT (P010031/S521)Medtronic Cardiac Rhythm Disease Management2016-01-13
MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION (P140011/S002)Siemens Medical Solutions USA, Inc.2016-01-13
CAPSUREFIX MRI LEAD (P090013/S212)Medtronic, Inc.2016-01-13
CAPSUREFIX LEAD; CAPSUREFIX NOVUS LEAD; SUREFIX LEAD;VITATRON CRYSTALLINE ACTIVE FIXATION LEAD; VITATRON CRYSTALLINE ACT (P930039/S145)Medtronic, Inc.2016-01-13
ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LV LEAD (P010015/S289)Medtronic, Inc.2016-01-13
Crown PRT Aortic Pericardial Heart Valve with PR Treatment (P060038/S026)Corcym Canada Corp2016-01-13
CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD; VITATRON EXCELLENCE LEAD PS+LEAD (P830061/S125)Medtronic Cardiac Rhythm Disease Management2016-01-13
TRANSVENE CS/SVC LEAD (P980050/S102)Medtronic, Inc.2016-01-13
SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD; TRANSVENE CS/SVC LEAD (P920015/S169)Medtronic, Inc.2016-01-13
DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S044)Dexcom, Inc.2016-01-13
SELECTSECURE LEAD (P030036/S081)Medtronic Cardiac Rhythm Disease Management2016-01-13
ATTAIN ABILITY LEAD, ATTAIN PERFORMA LEADS (P080006/S086)Medtronic, Inc.2016-01-13
FREEZOR MAX CARDIAC CRYOBLATION CATHETERS (P100010/S052)Medtronic Cryocath, LP2016-01-12
PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S030)Infusyn Therapeutics, LLC2016-01-12
REZOOM 3-PC MULTIFOCAL (P960028/S038)Johnson & Johnson Surgical Vision, Inc.2016-01-12
TENIS 3-PC MONOFOCAL-ZA9003 (P990080/S040)Johnson & Johnson Surgical Vision, Inc.2016-01-12
TECNIS 3PC MULTIFOCAL (P080010/S012)Johnson & Johnson Surgical Vision, Inc.2016-01-12
SENSAR 3PC & 1PC MONOFOCAL; TECNIS 1PC MONOFOCAL, 1PC MULTIFOCAL AND 1PC TORIC MONOFOCAL, 1PC OPTIBULE & 3PC OPTIBLUE (P980040/S064)Johnson & Johnson Surgical Vision, Inc.2016-01-12
MELAFIND (P090012/S006)Strata Skin Sciences, Inc.2016-01-12
FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CRYOABLATION DEVICE (P020045/S070)Medtronic Cryocath, LP2016-01-12
OCUFILCON D SOFT (HYDROPHILIC) CONTACT LENSES (P890023/S024)The Cooper Companies2016-01-11
THINPREP PROCESSORS (P950039/S034)Hologic, Inc.2016-01-11
MEDTRONIC MODEL 5019 HV SPLITTER/ADAPTOR (P920015/S168)Medtronic, Inc.2016-01-11
STAR EXCIMER LASER SYSTEM (P930016/S046)Amo Manufacturing USA, LLC2016-01-11
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S047)ABBOTT MEDICAL2016-01-11
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S079)W. L. Gore & Associates, Inc.2016-01-08
OPTISURE FAMILY OF HIGH VOLTAGE LEADS (P950022/S090)ABBOTT MEDICAL2016-01-08
SYNCHROMED INFUSION SYSTEM (P860004/S244)Medtronic, Inc.2016-01-08
STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY (P080028)Storz Medical AG2016-01-08
PERCEVAL SUTURELESS HEART VALVE (P150011)Corcym S.r.l.2016-01-08
NOVAFLEX+ DELIVERY SYSTEM, EDWARDS EXPANDABLE INTRODUCER SHEATH SET (P130009/S044)Edwards Lifesciences, LLC2016-01-08
AMPLATZER SEPTAL OCCLUDER (P000039/S051)ABBOTT MEDICAL2016-01-08
ARISTA AH, ARISTA AH FLEXITIP/ FLEXITIP XL/FLEXITIP XL-R (P050038/S028)Davol, Inc.2016-01-07
SEPRAFILM ADHESION BARRIER (P950034/S044)Baxter Healthcare Corporation2016-01-07
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S037)Syncardia Systems, LLC2016-01-07
INTEGRA(R) DERMAL REGENERATION TEMPLATE,INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE,OMNIGRAFT (TM) DERMAL REGENERATIO (P900033/S042)Integra Lifesciences Corp.2016-01-07
GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S047)W. L. Gore & Associates, Inc.2016-01-07
SPECTRUM BREAST IMPLANTS (P990075/S035)Mentor Worldwide, LLC2016-01-07
ON-X PROSTHETIC HEART VALVE (P000037/S044)On-X Life Technologies, Inc.2016-01-06
ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENS (P930014/S088)Alcon Laboratories, Inc.2016-01-06
ACRYSOF RESTOR POSTERIOR CHAMBER INTRAOCULAR LENS (P040020/S059)Alcon Research, Ltd.2016-01-06
PMMA SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS (P840060/S041)Alcon Laboratories2016-01-06
ACRYSOF IQ RESTORE +3.0D ADD POWER INTRAOCULAR LENS (P040020/S058)Alcon Research, Ltd.2016-01-06
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S014)Cook Ireland, Ltd.2016-01-06
IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S012)Medtronic, Inc.2016-01-06
SUPARTZ FX (P980044/S030)Seikagaku Corp.2016-01-06
PMMA MULTI-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS (P810032/S064)Alcon Laboratories2016-01-06
PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENS (P880087/S023)Alcon Laboratories2016-01-06
SPRINT QUATTRO MODEL 6946M LEAD (P920015/S155)Medtronic, Inc.2016-01-05
ADAPTA, VERSA, SENSIA IPG (P980035/S449)Medtronic, Inc.2016-01-05
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (26MM SIZE ONLY) (P140031/S004)Edwards Lifesciences, LLC2016-01-04
GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S044)Gynecare, Inc.2016-01-04
ASSURITY, ASSURITY+, ENDURITY, ENDURITY CORE FAMILY OF PACEMAKER DEVICES (P880086/S266)ABBOTT MEDICAL2016-01-04
CORDIS PRECISE NITINOL STENT SYSTEMS (P030047/S030)Cordis US Corporation2016-01-04
SAPIEN 3 TRANSCATHETER HEART VALVE (P140031/S005)Edwards Lifesciences, LLC2016-01-04
ALLURE AND ALLURE QUADRA FAMILY OF CRT-P DEVICES (P030035/S144)ABBOTT MEDICAL2016-01-04
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Every clearance here is in the API, with alerts when new ones post.