Atlas FDA

2011

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

Sort:Newest firstOldest first

◉ Watch 2011

RecordFirmDate
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR (P010021/S019)Ortho-Clinical Diagnostics, Inc.2011-08-02
AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILIES OF PACEMAKERS (P880086/S198)ABBOTT MEDICAL2011-08-02
CERVISTA HPV 16/18 (P080015/S005)Hologic, Inc.2011-08-02
EPIC HF/ATLAS+HF/PROMOTE/UNIFY FAMILIES OF CRT-DS (P030054/S180)ABBOTT MEDICAL2011-08-02
CADENCE/CURRENT/FORTIFY FAMILIES OF ICDS (P910023/S256)ABBOTT MEDICAL2011-08-02
OXFORD PARTIAL KNEE (P010014/S031)Biomet Manufacturing Corp2011-07-29
INTERSTIM FAMILY OF INS/LEAD/EXTENSION (P080025/S011)Medtronic Neuromodulation2011-07-29
CONCERTO II/CONSULTA/MAXIMO II (P010031/S263)Medtronic Cardiac Rhythm Disease Management2011-07-29
SYNCRA CRT-P, CONSULTA CRT-P, INSYNC CRT-P, INSYNC III CRT-P (P010015/S133)Medtronic, Inc.2011-07-29
ADAPTA, RELIA, SENSIA, & VERSA (P980035/S234)Medtronic, Inc.2011-07-29
LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S024)Medtimo, Inc.2011-07-29
INTERSTIM FAMILY OF INS/LEADS/EXTENSION (P970004/S119)Medtronic Neuromodulation2011-07-29
INTRATHECAL CATHETER MODELS 8731SC AND 8598A (P860004/S123)Medtronic, Inc.2011-07-29
SIDE CATHETER ACCESS PORT KITS/BULK/REFILLS KITS/BULK (P990034/S023)Medtronic, Inc.2011-07-29
THERAKOS CELLEX PHOTOPHERESIS SYSTEM (P860003/S057)Therakos Development Limited2011-07-29
CAPSURE EPI UNIPOLAR/BIOPOLAR LEADS (P950024/S017)Medtronic, Inc.2011-07-29
VNS THERAPY SYSTEM (P970003/S130)LivaNova USA, Inc.2011-07-29
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD (P840001/S191)Medtronic Neuromodulation2011-07-29
MAXIMO II/SECURA/VIRTUOSO II (P980016/S309)Medtronic Cardiac Rhythm Disease Management2011-07-29
ACTIVA FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS (P960009/S121)Medtronic, Inc.2011-07-29
SYNCHROMED II IMPLANTABLE INFUSION PUMP/INDURA 1P INTRATHECAL/SUTURELESS PUMP CONNECTOR REVISION/PROXIMAL CATHETER (P860004/S154)Medtronic, Inc.2011-07-29
DEFLUX INJECTABLE GEL (P000029/S069)Palette Life Sciences2011-07-28
ACCULINK CAROTID STENT SYSTEM (P040012/S036)Abbott Vascular2011-07-28
ADAPTA, RELIA, SENSIA, & VERSA (P980035/S233)Medtronic, Inc.2011-07-28
AMSONIC 9 STAGE WASH SYSTEM (P010014/S032)Biomet Manufacturing Corp2011-07-28
THE SPANNER TEMPORARY PROSTATIC STENT (P060010/S010)Srs Medical2011-07-28
ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P930014/S051)Alcon Laboratories, Inc.2011-07-28
REPLACING LASER EQUIPMENT (P010012/S269)Boston Scientific Corp2011-07-28
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S021)Smith & Nephew, Inc.2011-07-27
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY SYSTEM (P100023/S008)Boston Scientific Corp2011-07-27
CARPENTIER-EDWARDS PORCINE BIOPROSTHETIC VALVES (P870056/S040)Edwards Lifesciences, LLC2011-07-27
CAPSURE, CAPSURE Z NOVUS & VITATRON EXCELLENCE SS (P850089/S080)Medtronic Cardiac Rhythm Disease Management2011-07-27
INTEGRITY CORONARY STENT SYSTEMS (P030009/S057)Medtronic, Ireland2011-07-27
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHETIC VALVES (P860057/S072)Edwards Lifesciences, LLC2011-07-27
EDWARDS PORCINE STENTLESS BIOPROSTHETIC VALVES (P000007/S025)Edwards Lifesciences, LLC2011-07-27
CAPSURE, VITATRON CRYSTALLINE ACTFIX (P930039/S058)Medtronic, Inc.2011-07-27
CAPSURE, VITATRON CRYSTALINE AND VITATRON EXCELLENCE PS (P830061/S068)Medtronic Cardiac Rhythm Disease Management2011-07-27
ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S005)OraSure Technologies, Inc.2011-07-27
BLAZER II XP & BLAZER PRIME XP CATHETERS (P020025/S027)Boston Scientific2011-07-27
CHILLI II CATHETERS (P980003/S028)Boston Scientific Corp2011-07-27
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S121)Boston Scientific Corp2011-07-27
BLAZER II & BLAZER PRIME HTD CATHETERS (P920047/S046)Boston Scientific Corp2011-07-27
ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT (P100023/S010)Boston Scientific Corp2011-07-27
INTEGRITY CORONARY STENT SYSTEMS (P030009/S056)Medtronic, Ireland2011-07-27
ARCHITECT TOTAL PSA (P910007/S021)Abbott Laboratories2011-07-26
ACRYSOF INTROCULAR LENSES (P930014/S053)Alcon Laboratories, Inc.2011-07-26
ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S034)Alcon Research, Ltd.2011-07-26
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000, 7000TFX (P860057/S071)Edwards Lifesciences, LLC2011-07-26
AUTOMATED WASHER (P050044/S018)Stryker Corp.2011-07-26
ARCHITECT FREE PSA (P980007/S013)Abbott Laboratories2011-07-26
ADIANA PERMANENT CONTRACEPTION SYSTEM (P070022/S021)Hologic, Inc.2011-07-26
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S007)Boston Scientific Corp2011-07-25
TENDRIL, TENDRIL ST, TENDRIL STS, AND OPTISENSE LEADS (P960013/S062)ABBOTT MEDICAL2011-07-25
TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S093)Boston Scientific Corp2011-07-25
EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S168)ABBOTT MEDICAL2011-07-25
PASSIVE FIXATION SJ4 LEADS (P950022/S074)ABBOTT MEDICAL2011-07-25
EXPRESS AND EXPRESS CORONARY STENT SYSTEMS (P020009/S076)Boston Scientific Scimed, Inc.2011-07-25
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (P060008/S073)Boston Scientific Corp2011-07-25
PASSIVE PLUS, ISOFLEX S&P, AND ISOFLEX OPTIM LEADS (P960030/S032)ABBOTT MEDICAL2011-07-25
VERFLEX (LIBERTE) CORONARY STENT SYSTEMS (P040016/S074)Boston Scientific Scimed, Inc.2011-07-25
MICRONY FAMILY OF PACEMAKERS (P970013/S036)ABBOTT MEDICAL2011-07-25
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S193)ABBOTT MEDICAL2011-07-25
FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S073)ABBOTT MEDICAL2011-07-25
NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S080)Cochlear Americas2011-07-22
ELECSYS ANTI-HBC IMMUNOASSAY (P100031/S001)Roche Diagnostics Corp.2011-07-22
COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S052)Med-El Corp.2011-07-22
MED - EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S050)Med-El Corp.2011-07-22
PACEMAKER AND CRT-P DEVICES (P030035/S085)ABBOTT MEDICAL2011-07-22
COROX OTW-L BP LEADS (P070008/S025)Biotronik, Inc.2011-07-22
ARCHITECT FREE PSA (P980007/S020)Abbott Laboratories2011-07-22
ELECSYS ANTI-HBC IMMUNOASSAY (P100032/S001)Roche Diagnostics Corp.2011-07-22
ARCHITECT TOTAL PSA (P910007/S029)Abbott Laboratories2011-07-22
PACEMAKER AND CRT-P DEVICES (P880086/S205)ABBOTT MEDICAL2011-07-22
MEDTRONIC 350 SERIES IPG/ADAPTA/ADVISA/AT500/ENPULSE/ENRHYTHM/RELIA/SENSIA/SIGMA/VERSA IPGS (P980035/S232)Medtronic, Inc.2011-07-21
ACRYSOF RESTOR INTRAOCULAR LENSES (P840060/S037)Alcon Laboratories2011-07-21
CONCERTO II/CONSULTA/MAXIMO II (P010031/S262)Medtronic Cardiac Rhythm Disease Management2011-07-21
MAXIMO II/SECURA/VIRTUOSO II (P980016/S308)Medtronic Cardiac Rhythm Disease Management2011-07-21
NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S078)Cochlear Americas2011-07-21
GLOBAL VISION SCAN TVS PROOF-READER SYSTEM (P930014/S050)Alcon Laboratories, Inc.2011-07-21
ATTAIN STARFIX LEAD (P060039/S028)Medtronic, Inc.2011-07-21
DISPOABLE COVER & EPG SAFETY CABLE (P820003/S108)Medtronic Cardiac Rhythm Disease Management2011-07-21
DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1 (P900061/S105)Medtronic Cardiac Rhythm Disease Management2011-07-21
MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (P040044/S038)Cordis US Corporation2011-07-21
ATTAIN LEAD/CONSULTA CRT-P/INSYNC III/SYNCRA CRT-PS (P010015/S131)Medtronic, Inc.2011-07-21
VITATRON LEGACY IPG (P850051/S076)Medtronic, Inc.2011-07-21
MODEL 4296 ATTAIN ABILITY PLUS LV LEAD AND MODEL 4396 ATTAIN ABILITY STRAIGHT LV LEAD (P080006/S032)Medtronic, Inc.2011-07-21
CAPSURE, VITATRON CRYSTALINE AND VITATRON EXCELLENCE PS (P830061/S069)Medtronic Cardiac Rhythm Disease Management2011-07-21
CAPSURE, VITATRON CRYSTALLINE ACTFIX (P930039/S059)Medtronic, Inc.2011-07-21
TRANSVENE CS/SVC LEAD (W/POLYURETHANE SHEATH) (P980050/S064)Medtronic, Inc.2011-07-21
Y ADAPTOR/EXTENDER KIT/DF-1 PORT PIN PLUG/IS-1 CONNECTOR PORT PIN PLUG KIT/TOOL/LEAD ADAPTOR/SPRINT QUATTRO/SUBCUTANEOUS (P920015/S080)Medtronic, Inc.2011-07-21
ACRYSOF RESTOR INTRAOCULAR LENSES (P880087/S019)Alcon Laboratories2011-07-21
FILL/FLUSH EXTRACTION SYSTEM FOR ACRYSOF, AND ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S033)Alcon Research, Ltd.2011-07-21
VITATRON DA+C & VITATRON DA+T SERIES IPGS (P990001/S091)Medtronic, Inc.2011-07-21
JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S017)Allergan2011-07-21
SELECTSECURE LEAD/SLEEVE KIT (P030036/S034)Medtronic Cardiac Rhythm Disease Management2011-07-21
ACRYSOF RESTOR INTRAOCULAR LENSES (P810032/S060)Alcon Laboratories2011-07-21
CAPSURE EPICARDIAL PACING LEAD (P950024/S033)Medtronic, Inc.2011-07-21
CAPSURE, CAPSURE Z NOVUS & VITATRON EXCELLENCE SS (P850089/S081)Medtronic Cardiac Rhythm Disease Management2011-07-21
CAPSURE FIX LEAD & REVO MRI IPG (P090013/S030)Medtronic, Inc.2011-07-21
ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S032)Alcon Research, Ltd.2011-07-21
← Previous Next →

Track 2011 automatically

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