Atlas FDA

2011

2,224 FDA 510(k) clearances · PMA decision year

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◉ Watch 2011

RecordFirmDate
CADENCE FAMILY OF ICDS (P910023/S254)ABBOTT MEDICAL2011-04-04
CARELINK MONITOR & CARDIOSIGHT READER (P890003/S169)Medtronic, Inc.2011-04-04
ADVISA DR IPG (P980035/S134)Medtronic, Inc.2011-04-04
SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S070)St. Jude Medical, Inc.2011-04-04
MEDTRONIC MODEL 3625 EXTERNAL TEST STIMULATOR (P970004/S104)Medtronic Neuromodulation2011-04-04
EPIC HF/ATLAS+HF HAMILY OF CRT-DS (P030054/S177)ABBOTT MEDICAL2011-04-04
ARCHITECT AUSAB (P050051/S007)Abbott Laboratories, Inc.2011-04-04
ABBOTT ARCHITECT HBSAG AND ARCHITECT HBSAG CONFIRMATORY (P060007/S004)Abbott Laboratories2011-04-04
FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S075)ABBOTT MEDICAL2011-04-04
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S195)ABBOTT MEDICAL2011-04-04
CONSULTA CRT-D/CONCERTO II CRT-D/MAXIMO CRT-D ICDS (P010031/S150)Medtronic Cardiac Rhythm Disease Management2011-04-04
INFUSE BONE GRAFT (P000054/S027)Medtronic Sofamor Danek USA, Inc.2011-04-04
AXSYM CORE-M 2.0 (P060009/S005)Abbott Laboratories, Inc.2011-04-04
INFUSE BONE GRAFT (P050053/S018)Medtronic, Inc.2011-04-04
SECURA DR/VR, VIRTUOSO II DR/VR, MAXIMO II DR/VR ICDS (P980016/S187)Medtronic Cardiac Rhythm Disease Management2011-04-04
MICRONY FAMILY OF PACEMAKERS (P970013/S038)ABBOTT MEDICAL2011-04-04
MEDTRONIC MODEL 3625 EXTERNAL TEST STIMULATOR (P960009/S108)Medtronic, Inc.2011-04-04
ARCHITECT AUSAB (P050051/S005)Abbott Laboratories, Inc.2011-04-04
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S040)Medtronic Sofamor Danek USA, Inc.2011-04-04
MEDTRONIC MODEL 3625 EXTERNAL TEST STIMULATOR (P840001/S178)Medtronic Neuromodulation2011-04-04
ADAPTA/VERSA/SENSIA & RELIA IPGS (P980035/S208)Medtronic, Inc.2011-04-04
ST. JUDE MEDICAL BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VLAVES (P040021/S014)ABBOTT MEDICAL2011-04-01
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S014)Boston Scientific Corp2011-04-01
EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S012)Ferring Pharmaceuticals, Inc.2011-04-01
BVI 1% OVD-SODIUM HYALURONATE VISCOELASTIC (P960011/S019)Altacor , Ltd.2011-04-01
EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (P020009/S065)Boston Scientific Scimed, Inc.2011-04-01
VERIFLEX (LIBERTE) BARE METAL CORONARY STENT SYSTEM (P040016/S059)Boston Scientific Scimed, Inc.2011-04-01
BIRMINGHAM HIP RESURFACING SYSTEM (BHR) (P040033/S019)Smith & Nephew, Inc.2011-04-01
MEDTRONIC ATTAIN ABILITY PLUS MODEL 4296 LEAD (P080006/S002)Medtronic, Inc.2011-04-01
ARCTIC FRONT CARDIAC CRYOBLATION CATHETER (P100010/S002)Medtronic Cryocath, LP2011-04-01
VALIANT THORACIC STENT GRAFT SYSTEM (P100040)Medtronic Vascular2011-04-01
ADAPTA/RELIA/SENSIA/VERSA IPGS (P980035/S207)Medtronic, Inc.2011-03-31
EXPRESS2 MONORAIL & OTW (P020009/S066)Boston Scientific Scimed, Inc.2011-03-31
CHILLI II COOLED ABLATION CATHETER & CABLE (P980003/S024)Boston Scientific Corp2011-03-31
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S060)Boston Scientific Corp2011-03-31
BLAZER II XP CARDIAC ABLATION CATHETER/CABLE/BLAZER II HIGH TORQUE DISTAL (HTD) ABLATION CATHETER/CABLE/BLAZER PRIME (P920047/S044)Boston Scientific Corp2011-03-31
APEX MONORAIL & APEX OTW PTCA DILATATION CATHETER/MAVERICK2 MONORAIL PTCA CATHETER/MAVERICK OTW PTCA CATHETER/MAVERICK (P860019/S264)Scimed Life Systems, Inc.2011-03-31
CONCERTO II/CONSULTA/MAXIMO II CRT-DS (P010031/S239)Medtronic Cardiac Rhythm Disease Management2011-03-31
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S091)Boston Scientific Corp2011-03-31
BLAZER II XP CARDIAC ABLATION CATHETER & CABLE/BLAZER PRIME XP CARDIAC ABLATION CATHETER (P020025/S025)Boston Scientific2011-03-31
REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT & APPLIER (P070009/S013)Obtech Medical GmbH2011-03-31
MEDTRONIC REVO MRI SURESCAN PACING SYSTEM (P090013/S007)Medtronic, Inc.2011-03-31
EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S017)Boston Scientific Corp2011-03-31
C-FLEX INTRAOCULAR LENS MODEL 570C (P060011/S001)Rayner Intraocular Lenses , Ltd.2011-03-31
VITATRON DA+C & VITATRON DA+T SERIES IPGS (P990001/S085)Medtronic, Inc.2011-03-31
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE WITH WIRECLIP TORQUER (P900056/S103)Boston Scientific Corp2011-03-31
OVATIO CARDIAC RESYNCHRONIZATION THERAPY (CRT) AND SITUS OVER THE WIRE (OTW) LEFT VENTRICULAR (LV) LEAD (P060027/S030)MicroPort CRM USA, Inc.2011-03-31
STELID II BFT/BJF/STELIX BR/STELIX II BRF (P020030/S008)MicroPort CRM USA, Inc.2011-03-31
ARCHITECT FREE PSA (P980007/S011)Abbott Laboratories2011-03-31
MAXIMO II/SECURA/VIRTUOSO II ICDS (P980016/S285)Medtronic Cardiac Rhythm Disease Management2011-03-31
EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S005)Exactech, Inc.2011-03-31
ISOLINE 2CT & 2 CR (P980049/S063)MicroPort CRM USA, Inc.2011-03-31
VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S063)Boston Scientific Scimed, Inc.2011-03-31
IMPLANTABLE MINIATURE TELESCOPE (IMT) (P050034/S005)Samsara Vision, Inc.2011-03-31
MEDTRONIC ATTAIN ABILITY STRAIGHT MODEL 4396 LEFT VENTRICULAR LEAD (P080006/S004)Medtronic, Inc.2011-03-31
REVO MRI IPG (P090013/S008)Medtronic, Inc.2011-03-31
REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT AND APPLIER (P070009/S012)Obtech Medical GmbH2011-03-31
CAPSURE/SUREFIX/VITATRON CRYSTALLINE ACTFIX & PIROUET S+ (P930039/S048)Medtronic, Inc.2011-03-30
ACCULINK CAROTID STENT SYSTEM (P040012/S037)Abbott Vascular2011-03-30
ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS (P060007/S009)Abbott Laboratories2011-03-30
ACCULINK CAROTID STENT SYSTEM (P040012/S038)Abbott Vascular2011-03-30
CAPSURE FIX (P090013/S004)Medtronic, Inc.2011-03-30
CAPSURE EPICARDIAL PACING (P950024/S028)Medtronic, Inc.2011-03-30
ACCESSORY-UPSIZING SLEEVE/LEAD END PIN CAP (P900061/S099)Medtronic Cardiac Rhythm Disease Management2011-03-30
CAPSURE/CAPSURE MODEL/SERVICE KIT (P890003/S216)Medtronic, Inc.2011-03-30
ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S012)Spectranetics Corp.2011-03-30
MEDTRONIC SELECTSECURE LEAD MODEL 3830 (P030036/S004)Medtronic Cardiac Rhythm Disease Management2011-03-30
CAPSURE/Z NOVUS/VITATRON EXCELLENCE SS+/IMPULSE II (P850089/S073)Medtronic Cardiac Rhythm Disease Management2011-03-30
ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS (P060007/S011)Abbott Laboratories2011-03-30
SPRINT QUATTRO/SUBCUTANEOUS LEAD/TRANSVENE SVC LEAD (P920015/S073)Medtronic, Inc.2011-03-30
SELECTSECURE (P030036/S026)Medtronic Cardiac Rhythm Disease Management2011-03-30
TRANSVENE CS/SVC (P980050/S058)Medtronic, Inc.2011-03-30
CAPSURE/VITATRON CRYSTALINE & EXCELLENCE PS+ (P830061/S060)Medtronic Cardiac Rhythm Disease Management2011-03-30
PRESCISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S117)Boston Scientific Corp2011-03-30
MICRONY FAMILY OF PACEMAKERS (P970013/S039)ABBOTT MEDICAL2011-03-30
CONTINUOUS GLUCOSE MONITORING SYSTEM SOF-SENSOR, GLUCOSE SENSORS (P980022/S095)Medtronic Minimed2011-03-30
XACT CAROTID STENT SYSTEM (P040038/S021)Abbott Vascular, Inc.2011-03-30
ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS (P060007/S010)Abbott Laboratories2011-03-30
ARCHITECT HBSAG & ARCHITECT HBSAG CONFIRMATORY ASSAYS (P060007/S008)Abbott Laboratories2011-03-30
ATTAIN STARFIX (P060039/S022)Medtronic, Inc.2011-03-30
ATTAIN (P010015/S109)Medtronic, Inc.2011-03-30
ATTAIN ABILITY (P080006/S020)Medtronic, Inc.2011-03-30
CERVISTA HPV HR (P080014/S005)Hologic, Inc.2011-03-29
CERVISTA HPV 16/18 (P080015/S002)Hologic, Inc.2011-03-29
DIGENE HYBRID CAPTURE 2 (HC2) HPV DNA TEST & HIGH RISK HPV DNA TEST (P890064/S025)Qiagen Gaithersburg, Inc.2011-03-29
CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (P030002/S023)Bausch & Lomb, Inc.2011-03-29
MEDTRONIC REVO MRI SURESCAN PACING SYSTEM (P090013/S005)Medtronic, Inc.2011-03-28
LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S026)Zoll Manufacturing Corporation2011-03-28
BAUSCH & LOMB SOFLENS 66 & SOFLENS TORIC (ALPHAFILCON A) SOFT CONTACT LENSES (P960022/S008)Bausch & Lomb, Inc.2011-03-28
PRESCISION SPINAL CORD STIMULATOR SYSTEM (SCS) (P030017/S116)Boston Scientific Corp2011-03-28
MEDITEC MEL 80 EXCIMER LASER SYSTEM (P060004/S001)Carl Zeiss Meditec, Inc.2011-03-28
EVIA / ENTOVIS FAMILY OF PULSE GENERATORS (P950037/S091)Biotronik, Inc.2011-03-25
MEDTRONIC REVO MRI SURESCAN PACING SYSTEM (P090013/S003)Medtronic, Inc.2011-03-25
VNS THERAPY SYSTEM (P970003/S123)LivaNova USA, Inc.2011-03-25
JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S015)Allergan2011-03-25
MEDTRONIC CARELINK MONITOR MODEL 2490C, CARDIOSIGHT READER (P890003/S177)Medtronic, Inc.2011-03-25
PROTECTA XT CRT-D AND PROTECTA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION; MODEL SW009 (P010031/S171)Medtronic Cardiac Rhythm Disease Management2011-03-25
MEDTRONIC PROTECTA XT DR D314DRG, PROTECTA XT VR D314VRG, PROTECTA DR D334DRG, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980016/S211)Medtronic Cardiac Rhythm Disease Management2011-03-25
SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS (P980016/S282)Medtronic Cardiac Rhythm Disease Management2011-03-24
OXFORD PARTIAL KNEE SYSTEM (P010014/S030)Biomet Manufacturing Corp2011-03-24
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Track 2011 automatically

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