Atlas FDA

2010

1,845 FDA 510(k) clearances · PMA decision year

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◉ Watch 2010

RecordFirmDate
CONCERTO II/CONSULTA/MAXIMO II CRT-DS (P010031/S197)Medtronic Cardiac Rhythm Disease Management2010-06-03
ETHICON OMNEX SURGICAL SEALANT (P060029)ETHICON, Inc.2010-06-03
SECURA DR/VR/MAXIMO II VR/DR/VIRTUOSO II DR/VR ICDS (P980016/S239)Medtronic Cardiac Rhythm Disease Management2010-06-03
PMMA INTRAOCULAR LENSES (P810032/S057)Alcon Laboratories2010-06-02
KAPPA 400 DR/SR IPG (P970012/S067)Medtronic, Inc.2010-06-02
FALOPE-RING BAND AND APPLICATOR SYSTEMS (P870076/S010)Gyrus Acmi, Inc.2010-06-02
INSYNC/MARQUIS/II & III MARQUIS/II PROTECT/SENTRY/MAXIMO ICDS & CONCERTO/CONCERTO II/MAXIMO II/CONSULTA CRT-DS (P010031/S196)Medtronic Cardiac Rhythm Disease Management2010-06-02
KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENIA IPGS (P980035/S167)Medtronic, Inc.2010-06-02
X-STOP INTERSPINOUS SPACER SYSTEM (P040001/S017)Medtronic Sofamor Danek, Inc.2010-06-02
GEM/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/SECURA DR/VR (P980016/S238)Medtronic Cardiac Rhythm Disease Management2010-06-02
ACRYSOF INTRAOCULAR LENSES (P930014/S041)Alcon Laboratories, Inc.2010-06-02
PMMA INTRAOCULAR LENSES (P840060/S034)Alcon Laboratories2010-06-02
INSYNC CRT-P & INSYNC III CRT-P (P010015/S085)Medtronic, Inc.2010-06-02
ACRYSOF INTRAOCULAR LENSES (P880087/S016)Alcon Laboratories2010-06-02
DEMA IPG/C & T SERIES IPGS (P990001/S067)Medtronic, Inc.2010-06-02
ACRYSOF INTRAOCULAR LENSES (P040020/S025)Alcon Research, Ltd.2010-06-02
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S071)Boston Scientific Corp2010-06-01
ACRYSOF/ACRYSOF RESTOR/PMMA INTRAOCULAR LENSES (P930014/S040)Alcon Laboratories, Inc.2010-06-01
ACRYSOF/ACRYSOF RESTOR/PMMA INTRAOCULAR LENSES (P040020/S024)Alcon Research, Ltd.2010-06-01
MEDTRONIC NEUROMODULATION DEEP BRAIN STIMULATION SYSTEMS (P960009/S073)Medtronic, Inc.2010-06-01
ACRYSOF/ACRYSOF RESTOR/PMMA INTRAOCULAR LENSES (P810032/S056)Alcon Laboratories2010-06-01
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S095)Boston Scientific Corp2010-06-01
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S084)Boston Scientific Corp2010-06-01
DEFLUX INJECTABLE GEL (P000029/S065)Palette Life Sciences2010-06-01
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S028)Hologic, Inc.2010-06-01
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S082)Boston Scientific Corp2010-06-01
ACRYSOF/ACRYSOF RESTOR/PMMA INTRAOCULAR LENSES (P880087/S015)Alcon Laboratories2010-06-01
ACRYSOF/ACRYSOF RESTOR/PMMA INTRAOCULAR LENSES (P840060/S033)Alcon Laboratories2010-06-01
VOYAGER NC CORONARY DILATATION CATHETER (P810046/S237)Advanced Cardiovascular Systems, Inc.2010-06-01
DURASEAL DURAL SEALANT SYSTEM (P040034/S016)Integra LifeSciences Corporation2010-05-28
MOSAIC PORCINE BIOPROSTHESIS MODELS 305/310/305U (P990064/S033)Medtronic, Inc.2010-05-28
AMPLATZER SEPTAL OCCLUDER (P000039/S036)ABBOTT MEDICAL2010-05-28
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S006)Boston Scientific Corp2010-05-28
HANCOCK II PORCINE BIOPROSTHESIS MODELS T505/T510 (P980043/S026)Medtronic, Inc.2010-05-28
HANCOCK I LOW POROSITY & MODIFIED ORIFICE VALVED CONDUIT MODEL 150 (P790007/S025)Medtronic Heart Valves2010-05-28
KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM (P050027)KARL STORZ Endoscopy-America, Inc.2010-05-28
HANCOCK PORCINE BIOPROSTHESIS (P870078/S009)Medtronic, Inc.2010-05-28
FREESTYLE AORTIC ROOT BIOPROSTHESIS MODELS 995/955CS/995MS (P970031/S029)Medtronic, Inc.2010-05-28
AMPLATZER DUCT OCCLUDER (P020024/S029)ABBOTT MEDICAL2010-05-28
AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S013)ABBOTT MEDICAL2010-05-28
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S015)Siemens Healthcare Diagnostics2010-05-27
RESTOREULTRA IMPLANTABLE NEUROSTIMULATOR (P840001/S153)Medtronic Neuromodulation2010-05-27
DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S010)Siemens Healthcare Diagnostics2010-05-27
CELSIUS RMT THERMOCOOL CATHETER (P040036/S022)Biosense Webster, Inc.2010-05-27
GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM (P990066/S036)GE Healthcare2010-05-27
NAVISTAR RMT THERMOCOOL CATHETER (P030031/S029)Biosense Webster, Inc.2010-05-27
APEX PTCA DILATATION CATHETER (P860019/S255)Scimed Life Systems, Inc.2010-05-27
PRODISC L TOTAL REPLACEMENT (P050010/S005)Centinel Spine, LLC2010-05-26
PARADYM CRT 8750 (P060027/S023)MicroPort CRM USA, Inc.2010-05-26
SYMPHONY SR 2250 & DR 2550/RHAPSODY SR 2210/DR 2510/2530 & REPLY SR/DR & ESPRIT SR/DR (P950029/S052)MicroPort CRM USA, Inc.2010-05-26
PARADYM VR/DR (P980049/S056)MicroPort CRM USA, Inc.2010-05-26
PRODISC L TOTAL DISC REPLACEMENT (P050010/S006)Centinel Spine, LLC2010-05-26
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S033)W. L. Gore & Associates, Inc.2010-05-25
NEOMEND PROGEL PLEURAL AIR LEAK SEALANT (P010047/S003)Neomend, Inc.2010-05-25
ELEVESS (P050033/S008)Anika Therapeutics, Inc.2010-05-24
CONTAK RENEWAL TR (P030005/S062)Guidant Corp.2010-05-21
ETI-MAK-2PLUS & ETI-MAK-2 PLUS HBSAG CONFIRMATORY TEST KIT (P990038/S013)DiaSorin, Inc.2010-05-21
LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S019)Zoll Manufacturing Corporation2010-05-21
ETI-AB-AUK PLUS KIT (P990042/S009)DiaSorin, Inc.2010-05-21
PROMUS & XIENCE V OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S035)Abbott Vascular, Inc.2010-05-21
STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S025)Abbott Vascular Devices2010-05-21
ETI-COREK-IGMK PLUS KIT (P990044/S010)DiaSorin, Inc.2010-05-21
ANEURX AAADVANTAGE STENT GRAFT DELIVERY SYSTEM (P990020/S039)Medtronic Vascular2010-05-21
RELIANCE LEADS (P910073/S083)Boston Scientific2010-05-21
ETI-AB-COREK PLUS KIT (P990045/S010)DiaSorin, Inc.2010-05-21
ETI-AB-EBK PLUS KIT (P990041/S012)DiaSorin, Inc.2010-05-21
MULTILINK VISION & MULTI LINK MINI VISION OTW CORONARY STENT SYSTEMS (P020047/S019)Abbott Vascular2010-05-21
ETI-EBK PLUS KIT (P990043/S013)DiaSorin, Inc.2010-05-21
CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) (P030005/S064)Guidant Corp.2010-05-20
CONTAK RENEWAL 3 AND LIVIAN FAMILIES OF CRT-DS (P010012/S242)Boston Scientific Corp2010-05-20
ACTIVA FAMILY OF IMPLANTABLE STIMULATORS (P960009/S082)Medtronic, Inc.2010-05-20
INTERSTIM ICON PATIENT PROGRAMMER (P970004/S085)Medtronic Neuromodulation2010-05-20
PULSE GENERATOR (P010012/S243)Boston Scientific Corp2010-05-20
PERSONAL THERAPY MANAGER (MYPTM) (P860004/S127)Medtronic, Inc.2010-05-20
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (P810031/S037)Johnson & Johnson Surgical Vision, Inc.2010-05-20
CONFIENT AND VITALITY FAMILIES OF ICDS (P960040/S223)Boston Scientific2010-05-20
GE HEALTHCARE SENOGRAPHE ESSENTIAL DIGITAL MAMMOGRAPHY SYSTEM (P990066/S035)GE Healthcare2010-05-20
DUAL-CHAMBER ADAPTIVE-RATE PACEMAKER (P940031/S067)Boston Scientific2010-05-20
RESTORE IMPLANTABLE NEUROSTIMULATORS (P840001/S152)Medtronic Neuromodulation2010-05-20
TECNIS MULTIFOCAL ONE0PIECE INTRAOCULAR (IOL) MODEL ZMB00 (P980040/S033)Johnson & Johnson Surgical Vision, Inc.2010-05-20
VITROS IMMUNODIAGNOSTIC PRODUCT ANTI-HCV REAGENT PACK & CALIBRATOR (P010021/S018)Ortho-Clinical Diagnostics, Inc.2010-05-20
DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE (P000021/S013)Siemens Healthcare Diagnostics2010-05-19
CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL 3 RF, CONTAK RENEWAL 3 RF HE, LIVIAN SE, LIVIAN HE (P010012/S241)Boston Scientific Corp2010-05-19
LIVIAN/RENEWAL 3/RENEWAL 3RF/RENEWAL 3 AVT PULSE GENERATOR FAMILIES (P010012/S240)Boston Scientific Corp2010-05-19
MODEL 3120 ZOOM LATITUDE PROGRAMMER (P910077/S104)Boston Scientific2010-05-19
CONTAK RENEWAL TR FAMILY OF CRT-PS (P030005/S063)Guidant Corp.2010-05-19
CAPSURE SENSE/VITATRON (P830061/S051)Medtronic Cardiac Rhythm Disease Management2010-05-19
OPTISENSE 1999 LEAD (P960013/S058)ABBOTT MEDICAL2010-05-19
CONFIENT AND VITALITY HE FAMILIES OF PULSE GENERATORS (P960040/S221)Boston Scientific2010-05-19
AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS (P060022/S007)Bausch & Lomb, Inc.2010-05-19
VENTAK PRIZM, VENTAK PRIZM 2, VITALITY, VITALITY HE, VITALITY 2, VITALITY AVT, AND CONFIENT FAMILIES OF ICDS (P960040/S222)Boston Scientific2010-05-19
CAPSUREFIX NOVUS/VITATRON (P930039/S037)Medtronic, Inc.2010-05-19
BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S006)Bard Peripheral Vascular2010-05-18
VNS THERAPY SYSTEM/NCP/VNS PULSE GENERATORS (P970003/S109)LivaNova USA, Inc.2010-05-18
BAUSCH & LOMB TECHNOLAS T217Z ZYOPTIX LASER SYSTEM (P990027/S010)Technolas Perfect Vision GmbH2010-05-18
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S047)Boston Scientific Corp2010-05-17
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S036)Medtronic Sofamor Danek USA, Inc.2010-05-17
FPSA FLEX REAGENT CARTRIDGE (P020027/S009)Siemens Healthcare Diagnostics2010-05-17
DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST (P890064/S024)Qiagen Gaithersburg, Inc.2010-05-17
INFUSE BONE GRAFT (P000054/S024)Medtronic Sofamor Danek USA, Inc.2010-05-17
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Track 2010 automatically

Every clearance here is in the API, with alerts when new ones post.