Atlas FDA

2013

2,342 FDA 510(k) clearances · PMA decision year

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◉ Watch 2013

RecordFirmDate
DF-1 CONNECTOR PORT PIN PLUG, IS-1 CONNECTOR PORT PIN PLUG KIT, SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE SVC (P920015/S107)Medtronic, Inc.2013-04-11
TRANSVENE LEAD (P980050/S080)Medtronic, Inc.2013-04-11
CONSULTA CRT-P, SYNCRA CRT-P (P010015/S196)Medtronic, Inc.2013-04-11
CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELLENCE PS+ LEAD (P830061/S088)Medtronic Cardiac Rhythm Disease Management2013-04-11
CAPSUREFIX MRI LEAD (P090013/S089)Medtronic, Inc.2013-04-11
PROMOTE, PROMOTE+. PROMOTE RF, PROMOTE ACCEL, UNIFY, QUICKSITE, QUICKFLEX, (P030054/S244)ABBOTT MEDICAL2013-04-11
ELECSYS FREE PSA CALSET (P000027/S017)Roche Diagnostics Corp.2013-04-10
NUVASIVE'S PCM CERVICAL DISC (P100012/S003)Nuvasive, Inc.2013-04-10
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S010)Boston Scientific Corp2013-04-10
GENESIS NEUROSTIMULATION SYSTEMS (P010032/S070)ABBOTT MEDICAL2013-04-10
LCS TOTAL KNEE SYSTEM (P830055/S131)Depuy, Inc.2013-04-10
PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S011)Infusyn Therapeutics, LLC2013-04-09
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD) HEALON,HEALON GV, AND HEALON5 PRODUCTS (P810031/S047)Johnson & Johnson Surgical Vision, Inc.2013-04-09
AMO HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (P110007/S002)Johnson & Johnson Surgical Vision, Inc.2013-04-09
PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S014)Infusyn Therapeutics, LLC2013-04-09
VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY (P020011/S007)Gen-Probe2013-04-08
ARISTA AH ABSORABLE HEMOSTAT (P050038/S016)Davol, Inc.2013-04-05
MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S012)Mentor Corp.2013-04-05
ENDOTOXIN TEST METHOD (P090022/S016)Lenstec, Inc.2013-04-05
BRAVA CRT-D, CONCERTOII CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA S CRT-D, VIVA XT (P010031/S366)Medtronic Cardiac Rhythm Disease Management2013-04-04
VITATRON C20 SR IPG,VITATRON C60 DR IPG,VITATRON T20 SR IPG,VITATRON T60 DR IPG (P990001/S110)Medtronic, Inc.2013-04-04
INTRINSIC ICD,MARQUIS DR ICD,MARQUIS VR ICD,MAXIMO DR ICD,MAXIMO VR ICD,PROTECTA ICD,PROTECTA XT ICD, SECURA ICD,VIRTUOS (P980016/S404)Medtronic Cardiac Rhythm Disease Management2013-04-04
MAXIMOII ICD, PROTECTA ICD,PROTECTA XT ICD, SECURA ICD, VIRTUOSOII DR/VR ICD (P980016/S403)Medtronic Cardiac Rhythm Disease Management2013-04-04
EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER (P910001/S059)Spectranetics Corp.2013-04-04
ADAPTA,VERSA,SENSIA IPG,ADVISA DRIPG,ADVISA MRI IPG, RELIA IPG (P980035/S314)Medtronic, Inc.2013-04-04
PROGEL PLEURAL AIR LEAK SEALANT (P010047/S022)Neomend, Inc.2013-04-04
CONSULTA CRT-P,SYNCRA CRT-P (P010015/S194)Medtronic, Inc.2013-04-04
VISCOAT, DUROVISC AND DISCOVISC DEVICES OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S040)Alcon Research, Ltd.2013-04-04
REVO MRI IPG (P090013/S088)Medtronic, Inc.2013-04-04
BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D,CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAX (P010031/S367)Medtronic Cardiac Rhythm Disease Management2013-04-04
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S053)Alcon Laboratories2013-04-04
PERENNIADURA MODEL 303 LEAD (P970003/S157)LivaNova USA, Inc.2013-04-03
MEDTRONIC EVERA XT DR, EVERA XT VR, EVERA S DR, EVERA S VR IMPLANTABLE CARDIOVERTER DEFINRILLATORS (P980016/S382)Medtronic Cardiac Rhythm Disease Management2013-04-03
MEDTRONIC CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS (P890003/S259)Medtronic, Inc.2013-04-03
PULSE AND PULSE DUO GENERATORS, DEMIPULSE AND DEMIPULSE DUO GENERATORS, ASPIREHC MODEL 105 GENERATOR (P970003/S159)LivaNova USA, Inc.2013-04-03
GYNECARE THERMACHOICE III UTERINE THERAPY SYSTEM (P970021/S037)Gynecare, Inc.2013-04-03
PIPLINE TM EMBOLIZATION DEVICE (P100018/S006)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2013-04-02
3F AORTIC BIOPROSTHESIS (P060025/S011)Medtronic, Inc.2013-04-02
DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S004)DePuy Orthopaedics, Inc.2013-04-02
PATHWAY ANTI-HER-2 (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S016)Ventana Medical Systems, Inc.2013-04-02
HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S018)Medtronic2013-04-02
NMP22 BLADDERCHEK TEST (P940035/S009)Abbott Diagnostics Scarborough, Inc.2013-04-02
PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S006)Ventana Medical Systems, Inc.2013-04-02
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S006)Ventana Medical Systems, Inc.2013-04-02
BLAZER PRIME HTD (P920047/S056)Boston Scientific Corp2013-04-01
THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS) (P060040/S025)ABBOTT MEDICAL2013-04-01
BLAZER PRIME XP CARDIAC ABLATION CATHETERS (P020025/S039)Boston Scientific2013-04-01
THORATEC VENTRICULAR ASSIST DEVICE (P870072/S052)Thoratec Laboratories Corp.2013-04-01
OPEN PIVOT HEART VALVE (P990046/S031)Medtronic Ats Medical, Inc.2013-03-29
PCM CERVICAL DISC (P100012/S002)Nuvasive, Inc.2013-03-29
ADVISA MRI (A2DR01) (P980035/S315)Medtronic, Inc.2013-03-28
CONSULTA CRT-P,SYNCRA CRT-P (P010015/S192)Medtronic, Inc.2013-03-28
BRAVA CRT-P,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D (P010031/S364)Medtronic Cardiac Rhythm Disease Management2013-03-28
SPACE DATA COLLECTOR AND NIKON ROUTER (P980016/S401)Medtronic Cardiac Rhythm Disease Management2013-03-28
NEXGEM LPS-FLEX MOBILE AND LPS-MOBILE KNEES (P060037/S020)Zimmer, Inc.2013-03-28
REVO MRI IPG (P090013/S086)Medtronic, Inc.2013-03-28
ADAPTA,VERSA,SENSIA IPG,ADVISA DR IPG,ADVISA DR MRI IPG,RELIA IPG (P980035/S312)Medtronic, Inc.2013-03-28
SNS URINARY INS INTERSTIM FAMILY (P970004/S146)Medtronic Neuromodulation2013-03-27
SILICONE-FILLED NATRELLE BIOCELL TEXTURED SHELL SURFACE (P020056/S019)Allergan2013-03-27
INFUSE BONE GRAFT (P000054/S038)Medtronic Sofamor Danek USA, Inc.2013-03-27
SALINE FILLED NATRELLE BIOCELL TEXTURED SHELL SURFACE (P990074/S025)Allergan2013-03-27
ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S073)Medtronic, Inc.2013-03-27
RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S008)Medtronic Vascular2013-03-27
HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S017)Medtronic2013-03-27
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S053)Medtronic Sofamor Danek USA, Inc.2013-03-27
INFUSE BONE GRAFT (P050053/S030)Medtronic, Inc.2013-03-27
NATRELLE SILICONE -FILLED BREAST IMPLANTS (P040046/S001)Allergan2013-03-27
LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S030)Medtimo, Inc.2013-03-27
SNS BOWEL INS INTERSTIM FAMILY (P080025/S042)Medtronic Neuromodulation2013-03-27
CONCERTO ICD,CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, PROTECTA CRT-D, DF4 CRT-D, XT CRT-D, XT DR, XT DF4 CRT-D (P010031/S310)Medtronic Cardiac Rhythm Disease Management2013-03-26
BRAVA CRT-D, CONCENTOIICRT-D, CONSULTA ICD,MAXIMOII CRT,PROTECTA CRT-D, PROTECAXT CRT-D,VIVA S CRT-D,VIVAXT CRT-D (P010031/S365)Medtronic Cardiac Rhythm Disease Management2013-03-26
PARADYM VR AND DR, PARADYM RF VR AND DR (P980049/S081)MicroPort CRM USA, Inc.2013-03-26
PARADYM/PARADYM RF CRT-D (P060027/S048)MicroPort CRM USA, Inc.2013-03-26
ADAPTA,VERSA,SENSIA,ADVISA DR IPG,ADVISA DR MRI IPG,RELIA IPG (P980035/S313)Medtronic, Inc.2013-03-26
CAPSUREFIX MRI LEAD (P090013/S084)Medtronic, Inc.2013-03-26
INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL (P100027/S005)Ventana Medical Systems, Inc.2013-03-26
CONSULTA CRT-P, SYNCRA CRT-P (P010015/S193)Medtronic, Inc.2013-03-26
ESTEEM (P090018/S014)Envoy Medical Corporation2013-03-26
AKREOS INTRAOCULAR LENS (P060022/S015)Bausch & Lomb, Inc.2013-03-26
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S021)Beckman Coulter, Inc.2013-03-26
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM (P850048/S032)Beckman Coulter, Inc.2013-03-26
ADVISA DR IPG, AT501 DDDRP PACING SYSTEM IPG (P980035/S272)Medtronic, Inc.2013-03-26
DEXCOM G4 PLANTINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S003)Dexcom, Inc.2013-03-26
REPLY SR AND DR, ESPRIT SR AND DR (P950029/S078)MicroPort CRM USA, Inc.2013-03-26
MAXIMOII ICD (P980016/S402)Medtronic Cardiac Rhythm Disease Management2013-03-26
ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM (P090026/S005)Beckman Coulter, Inc.2013-03-26
ENTRUST ICD, PROTECTA DF4 ICD, ICD, XT DF4 ICD, ICD, SECURA DF4 ICD, SECURA ICD, VIRTUOSO ICD VIRTUOSO II DR/VR ICD (P980016/S357)Medtronic Cardiac Rhythm Disease Management2013-03-26
PARADYM CRT-D, PARADYM RF CRT-D (P060027/S049)MicroPort CRM USA, Inc.2013-03-26
PARADYM/PARADYM RF ICD (P980049/S080)MicroPort CRM USA, Inc.2013-03-26
RENO MRI IPG (P090013/S087)Medtronic, Inc.2013-03-26
STRATOS (P070008/S039)Biotronik, Inc.2013-03-25
ECURO, EFFECTA, ENTOVIS, ESTELLA, EVIA (P950037/S119)Biotronik, Inc.2013-03-25
LUMAX (P050023/S061)Biotronik, Inc.2013-03-25
PROMUS ELEMENT PLUS EVEROLIMUS-ELEUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S035)Boston Scientific Corp2013-03-25
ENDURANT STENT GRAFT SYSTEM, ENDURANT II STENT GRAFT SYSTEM (P100021/S023)Medtronic Vascular2013-03-25
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S022)Beckman Coulter, Inc.2013-03-25
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S106)Cochlear Americas2013-03-22
SYNCHROMED II PUMP (P860004/S188)Medtronic, Inc.2013-03-22
IPRO2 RECORDER, IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM (P980022/S131)Medtronic Minimed2013-03-22
CORMET HIP RESURFACING SYSTEM (P050016/S009)Corin USA2013-03-22
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Every clearance here is in the API, with alerts when new ones post.