Atlas FDA

2009

1,492 FDA 510(k) clearances · PMA decision year

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◉ Watch 2009

RecordFirmDate
CAPSURE VDD LEAD (P890003/S171)Medtronic, Inc.2009-05-08
SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR (P980016/S193)Medtronic Cardiac Rhythm Disease Management2009-05-08
CAPSUREFIX NOVUS LEAD (P930039/S032)Medtronic, Inc.2009-05-08
OVATIO CRT (P060027/S014)MicroPort CRM USA, Inc.2009-05-08
ACTIVA DEEP BRAIN STIMULATION (DBS) (P960009/S065)Medtronic, Inc.2009-05-07
XACT CAROTID STENT SYSTEM (P040038/S018)Abbott Vascular, Inc.2009-05-07
OSTEONICS ABC/TRIDENT SYSTEMS (P000013/S009)Howmedica Osteonics Corp.2009-05-07
CADENCE FAMILY ICDS (P910023/S206)ABBOTT MEDICAL2009-05-07
TAXUS LIBERTE PACLITAXEL-ELUTING STENT SYSTEM (MONORAIL & OVER-THE-WIRE) (P060008/S010)Boston Scientific Corp2009-05-07
RIATA ST OPTIM/DURATA LEADS (P950022/S056)ABBOTT MEDICAL2009-05-07
ATLAS II+ HF CRT-D & PROMOTE HE CRT-D (P030054/S114)ABBOTT MEDICAL2009-05-07
ANGIO-SEAL VASULAR CLOSURE DEVICE (P930038/S058)Terumo Medical Corporation2009-05-07
TAXUS LIBERTE PACLITAXEL-ELUTING STENT SYSTEM (P060008/S015)Boston Scientific Corp2009-05-07
EPIC HF FAMILY CRT-DS (P030054/S122)ABBOTT MEDICAL2009-05-07
SJM MODEL 3510 PROGRAMMER(FOR ATLAS II CRT-D)/MERLIN MODEL 3650 PROGRAMMER( FOR ATLAS II & PROMOTE CRT-D) (P910023/S200)ABBOTT MEDICAL2009-05-07
CAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS (P860057/S042)Edwards Lifesciences, LLC2009-05-07
LCS TOTAL KNEE SYSTEM (P830055/S110)Depuy, Inc.2009-05-06
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S063)Cordis Corp.2009-05-06
DEFLUX INJECTABLE GEL (P000029/S055)Palette Life Sciences2009-05-05
DEXCOM SEVEN SYSTEMS (P050012/S018)Dexcom, Inc.2009-05-05
BAUSCH & LOMB SOFLENS (POLYMACON) CONTACT LENS (N16895/S091)Bausch & Lomb, Inc.2009-05-05
BAUSCH & LOMB PUREVISION/PUREVISION 2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES (P980006/S014)Bausch & Lomb, Inc.2009-05-05
FLOSEAL HEMOSTATIC MATRIX 5 ML/10 ML KIT (P990009/S026)Baxter Healthcare Corp2009-05-04
SJM BIOCOR/BIOCOR SUPRA VALVES (P040021/S008)ABBOTT MEDICAL2009-05-04
SYMPHONY SR/DR/RHAPSODY SR/DR/REPLY VR/DR (P950029/S044)MicroPort CRM USA, Inc.2009-05-01
SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S016)Hologic, Inc.2009-05-01
BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX LASER SYSTEM (P990027/S011)Technolas Perfect Vision GmbH2009-05-01
BIOGLUE SURGICAL ADHESIVE (P010003/S013)Cryolife, Inc.2009-05-01
CARELINK MONITOR (P890003/S154)Medtronic, Inc.2009-05-01
VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S008)Siemens Healthcare Diagnostics, Inc.2009-05-01
STARCLOSURE SE VASCULAR CLOSURE SYSTEM (P050007/S013)Abbott Vascular Devices2009-05-01
CONCERTO/CONCERTO II CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D (P010031/S132)Medtronic Cardiac Rhythm Disease Management2009-05-01
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S085)Boston Scientific Corp2009-05-01
OVATIO CRT (P060027/S013)MicroPort CRM USA, Inc.2009-05-01
VIRTUOSO/VIRTUOSO II DR/VR ICD/SECURA DR/VR ICD/MAXIMO II DR/VR ICD (P980016/S165)Medtronic Cardiac Rhythm Disease Management2009-05-01
OVATIO VR/DR (P980049/S047)MicroPort CRM USA, Inc.2009-05-01
SYNCHROMED INFUSION SYSTEM (P860004/S107)Medtronic, Inc.2009-05-01
MED-EL COCHLEAR IMPLANT SYSTEMS (P000025/S039)Med-El Corp.2009-04-30
ACTIVA RC/PC IMPLANTABLE NEUROSTIMULATORS (P960009/S066)Medtronic, Inc.2009-04-30
CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM (P910023/S207)ABBOTT MEDICAL2009-04-30
INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S064)Medtronic Neuromodulation2009-04-30
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S137)Medtronic Neuromodulation2009-04-30
INTERSTIM II IMPLANTABLE NEUROSTIMULATOR (P970004/S072)Medtronic Neuromodulation2009-04-30
SJM MASTERS VALVED GRAFT (P810002/S070)ABBOTT MEDICAL2009-04-30
PARAGON RIGID GAS PERMEABLE CONTACT LENS (PAFLUFOCON C) AND PARAGON RIGID GAS PERMEABLE CONTACT LENS (PAFLUFOCON B) (P870024/S046)CooperVision, Inc.2009-04-29
GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S026)Gynecare, Inc.2009-04-28
LATTITUDE INDUCTIVE COMMUNICATOR (P910077/S092)Boston Scientific2009-04-28
ATTAIN OTW (P010015/S067)Medtronic, Inc.2009-04-28
PROMOTE / PROMOTE+ CRT-D (P030054/S121)ABBOTT MEDICAL2009-04-28
CADENCE ICD SYSTEM (P910023/S208)ABBOTT MEDICAL2009-04-28
MYNX VASCULAR CLOSURE DEVICE (P040044/S013)Cordis US Corporation2009-04-28
PRIZM & VITALITY FAMILIES OF PULSE GENERATORS (P960040/S192)Boston Scientific2009-04-28
SELECT SECURE (P030036/S013)Medtronic Cardiac Rhythm Disease Management2009-04-28
CONTAK & RENEWAL FAMILIES OF PULSE GENERATORS (P010012/S205)Boston Scientific Corp2009-04-28
CAPSURE SENSE MODEL 4074 AND 4574 (P830061/S046)Medtronic Cardiac Rhythm Disease Management2009-04-28
EPIC HF CRT-D SYSTEM (P030054/S123)ABBOTT MEDICAL2009-04-28
SJM IMPLANTABLE ICDS & CRT-DS (P910023/S205)ABBOTT MEDICAL2009-04-28
TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S008)Cerenovus, Inc.2009-04-28
CAPSURE SP NOVUS MODELS 4592 AND 4092 (P930039/S031)Medtronic, Inc.2009-04-28
SPRINT QUATTRO, SPRINT QUATTRO SECURE MODELS 6947 AND 6935 (P920015/S053)Medtronic, Inc.2009-04-28
LATITUDE INDUCTIVE COMMUNICATOR (P910077/S093)Boston Scientific2009-04-28
CONSULTA/MAXIMO II/CONCERTO II CRT-DS (P010031/S137)Medtronic Cardiac Rhythm Disease Management2009-04-27
SECURA MAXIMO II, VIRTUOSO DR/VR II FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P980016/S170)Medtronic Cardiac Rhythm Disease Management2009-04-27
OPEN PIVOT BI-LEAFLET HEART VALVE (P990046/S019)Medtronic Ats Medical, Inc.2009-04-24
THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD) SYSTEM (P870072/S041)Thoratec Laboratories Corp.2009-04-24
MODEL 2090 MEDTRONIC / VITATRON CARELINK PROGRAMMER (P890003/S166)Medtronic, Inc.2009-04-24
GORE VIABAHN ENDOPROSTHESIS (P040037/S018)W. L. Gore & Associates, Inc.2009-04-24
INSYNC III (P010015/S064)Medtronic, Inc.2009-04-24
GORE HELEX SEPTAL OCCLUDER (P050006/S011)W. L. Gore & Associates, Inc.2009-04-24
POWERSAIL CORONARY DILATATION CATHETER (P810046/S229)Advanced Cardiovascular Systems, Inc.2009-04-24
MAXIMO VR/DR/MARQUIS VR/DR/INTRINSIC/VIRTUOSO/ENTRUST/SECURA DR/VR/MAXIMO II DR/VR (P980016/S192)Medtronic Cardiac Rhythm Disease Management2009-04-24
CONSULTA, CONCERTO II, MAXIMO II CRT-D AND SECURA, VIRTUOSO II, MAXIMO II ICDS (P010031/S146)Medtronic Cardiac Rhythm Disease Management2009-04-24
INSYNC II/III MARQUIS/INSYNC II PROTECT/INSYNC SENTRY/INSYNC MAXIMO/CONCERTO/CONSULTA CRT-D/MAXIMO II CRT-D (P010031/S153)Medtronic Cardiac Rhythm Disease Management2009-04-24
CONSULTA, CONCERTO II, MAXIMO II CRT-D AND SECURA, VIRTUOSO II, MAXIMO II ICDS (P980016/S183)Medtronic Cardiac Rhythm Disease Management2009-04-24
SJM MASTERS HP VALVED GRAFT WITH GELWEAVE VALSALVA TECHNOLOGY (P810002/S069)ABBOTT MEDICAL2009-04-23
RESTYLANE INJECTABLE GEL (P040024/S038)Q-Med AB2009-04-23
TALENT THORACIC STENT GRAFT SYSTEM (P070007/S009)Medtronic Vascular2009-04-22
INSYNC FAMILIES OF ICDS/CONSULTA CRT-D/CONCERTO ICD/MAXIMO II CRT-D/CONCERTO II CRT-D (P010031/S152)Medtronic Cardiac Rhythm Disease Management2009-04-22
ENTRUST/VIRTUOSO/MAXIMO II/SECURA/MARQUIS/MAXIMO/INTRINSIC 35J/30/VIRTUOSO II ICDS (P980016/S189)Medtronic Cardiac Rhythm Disease Management2009-04-22
OLYMPIC COOL-CAP SYSTEM (P040025/S007)Natus Medical Incorporated2009-04-22
SMART NITINOL STENT SYSTEM & SMART CONTROL NITINOL STENT SYSTEM (P020036/S013)Cordis US Corporation2009-04-22
NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S009)Allergan2009-04-22
S.M.A.R.T. NITINOL STENT SYSTEM AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036/S014)Cordis US Corporation2009-04-22
PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS (P030047/S017)Cordis US Corporation2009-04-22
VARIOUS FAMILIES OF PACEMAKERS (P980035/S108)Medtronic, Inc.2009-04-21
STINGER, STINGER S, SCORPION, SCORPION *2 ABLATION CATHETERS AND TEMPLINK EXTENSION CABLES (P000020/S012)Boston Scientific Corp2009-04-21
INSYNC CRT-D/CONCERTO & VARIOUS INSYNC FAMILIES OF ICDS (P010031/S115)Medtronic Cardiac Rhythm Disease Management2009-04-21
INSYNC & INSYNC III CRT-P (P010015/S049)Medtronic, Inc.2009-04-21
KAPPA 400 DR & SR PACEMAKERS (P970012/S039)Medtronic, Inc.2009-04-21
VARIOUS FAMILIES OF ICDS (P980016/S146)Medtronic Cardiac Rhythm Disease Management2009-04-21
VARIOUS FAMILIES OF PACEMAKERS (P990001/S040)Medtronic, Inc.2009-04-21
PLASMAT SECURA HEPARIN-INDUCED EXTRACORPOREAL LDL APHERESIS SYSTEM (H.E.L.P.) (P940016/S012)B. Braun Avitum AG2009-04-20
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S022)Bayer Pharma AG2009-04-20
PLASMAT SECURA HEPARIN-INDUCED EXTRACORPOREAL LDL APHERESIS SYSTEM (H.E.L.P.) (P940016/S011)B. Braun Avitum AG2009-04-20
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S016)Smiths Medical Asd, Inc.2009-04-20
RESTORE PRIME, PRIMEADVANCED, RESTORE RECHARGEABLE, RESTOREULTRA, RESTOREADVANCED RECHARGEABLE (P840001/S131)Medtronic Neuromodulation2009-04-20
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY PRODUCTS (N17600/S024)Davol Inc., Sub. C. R. Bard, Inc.2009-04-17
C2A-TAPER ACETABULAR SYSTEM (P050009/S004)Biomet, Inc.2009-04-17
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY PRODUCTS (P800002/S016)C.R. Bard, Inc.2009-04-17
POWERLINK SYSTEM (P040002/S022)Endologix, LLC2009-04-17
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Track 2009 automatically

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