Atlas FDA

2006

1,074 FDA 510(k) clearances · PMA decision year

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◉ Watch 2006

RecordFirmDate
EXPRESS2 CORONARY STENT SYSTEM (P020009/S027)Boston Scientific Scimed, Inc.2006-06-08
ST JUDE MEDICAL PACEMAKERS (P880086/S121)ABBOTT MEDICAL2006-06-08
ROTOBLATOR ROTATIONAL ANGIOPLASTY SYSTEM WIRE (P900056/S088)Boston Scientific Corp2006-06-08
CUTTING BALLOON (P950020/S016)Boston Scientific Corp2006-06-08
SDX PERMANENT PACEMAKERS (P960013/S014)ABBOTT MEDICAL2006-06-08
LIBERTE CORONARY STENT SYSTEM (P040016/S010)Boston Scientific Scimed, Inc.2006-06-08
ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL (P050042)Abbott Laboratories, Inc.2006-06-07
PEPGEN P-15 DENTAL BONE GRAFTING MATERIAL AND BIOLOGIC COMPONENT (P990033/S007)Ceramed Corp.2006-06-06
TENDRIL ST LEAD MODELS 1888TC AND 1882TC (P960013/S018)ABBOTT MEDICAL2006-06-06
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR & PRODUCTS HBSAG CONFIRMATORY KIT (P000044/S012)Ortho-Clinical Diagnostics, Inc.2006-06-05
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S010)Ortho-Clinical Diagnostics, Inc.2006-06-05
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR (P000014/S014)Ortho-Clinical Diagnostics, Inc.2006-06-05
HANCOCK II BIOPROSTHESIS, MODELS T505 AND T510 (P980043/S009)Medtronic, Inc.2006-06-05
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S005)Ortho-Clinical Diagnostics2006-06-05
MOSAIC PORCINE BIOPROSTHESIS, MODELS 305, 310 (P990064/S014)Medtronic, Inc.2006-06-05
JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS (P050047)Allergan2006-06-02
ABBOTT ARCHITECT AUSAB (P050051)Abbott Laboratories, Inc.2006-06-01
RENEWAL RF CRT-D FAMILY OF DEVICES (P010012/S128)Boston Scientific Corp2006-06-01
ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM (P020018/S009)Cook, Inc.2006-06-01
TRUFILL N-BUTYL CYANOACRYLATE (NBCA) LIQUID EMBOLIC SYSTEM (P990040/S004)Cerenovus, Inc.2006-06-01
AXSYM HBSAG, HBSAG CONFIRMATORY, AND AXSYM HBSAG CONTROLS (P050049)Abbott Laboratories, Inc.2006-06-01
COMBI 40 + COCHLEAR IMPLANT SYSTEM AND PULSAR COCHLEAR IMPLANT SYSTEM (P000025/S020)Med-El Corp.2006-05-31
BOSTON EQUALENS (ITAFLUOROFOCON A AND OPRIFOCON A) (P860022/S056)Bausch & Lomb2006-05-30
RIGID GAS PERMEABLE CONTACT LENSES (BOSTON ORTHOKERATOLOGY) (P010062/S004)Bausch & Lomb2006-05-30
DURALOC OPTION CERAMIC HIP SYSTEM (P040023/S007)DePuy Orthopaedics, Inc.2006-05-26
TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S001)Biomet Microfixation, Inc.2006-05-26
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S037)Cochlear Americas2006-05-25
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S014)Boston Scientific Corp2006-05-24
BARD TEGRESS URETHRAL IMPLANT (P030030/S003)C.R. Bard, Inc.2006-05-23
CADENCE, CADET, CANTOUR, ANGSTROM, PROFILE,PHOTON, EPIC AND ATLAS ICD FAMILIES (P910023/S107)ABBOTT MEDICAL2006-05-23
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S018)CooperSurgical, Inc.2006-05-23
EPIC HF AND ATLAS + HF CRT-D FAMILIES (P030054/S028)ABBOTT MEDICAL2006-05-23
CONTAK RENEWAL FAMILY DEVICES (P010012/S103)Boston Scientific Corp2006-05-19
VITALITY FAMILY OF ICDS (P960040/S108)Boston Scientific2006-05-19
CARPENTIER-EDWARDS PERIMOUNT PLUS MITRAL PERICARDIAL BIOPROSTHESIS MODEL 6900PTFX (P860057/S033)Edwards Lifesciences, LLC2006-05-18
ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P850048/S020)Beckman Coulter, Inc.2006-05-18
ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMUNOASSAY SYSTEMS (P970038/S008)Beckman Coulter, Inc.2006-05-18
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER (P020026/S014)Cordis Corp.2006-05-17
ENDOLOGIX POWERLINK SYSTEM (P040002/S005)Endologix, LLC2006-05-17
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S008)Beckman Coulter, Inc.2006-05-16
LEGEND PLUS FAMILY OF PACEMAKERS (P930022/S003)Medtronic, Inc.2006-05-12
MEDTRONIC VASCULAR NC STORMER MX2 BALLON DILATATION CATHETER (P790017/S085)Medtronic, Ireland2006-05-12
MEDTRONIC CONCERTO MODEL C154DWK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND CONCERTO VIRTUOSO V1.0 SOFTWARE APPLICATION (P010031/S031)Medtronic Cardiac Rhythm Disease Management2006-05-12
THINLINE (P960004/S036)Boston Scientific2006-05-12
INSYNC/INSYNC III CRT-IPGS, MODEL 8040/8042 (P010015/S019)Medtronic, Inc.2006-05-12
CARPENTIER EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S034)Edwards Lifesciences, LLC2006-05-12
VARIOUS FAMILIES OF PACEMAKERS, REVEAL PLUS & BOSS (P890003/S097)Medtronic, Inc.2006-05-12
CONTAK RENEWAL TR (P030005/S034)Guidant Corp.2006-05-12
MEDTRONIC VIRTUOSO DR/VR MODELS D154A WG/D154VWC ICDS, CONCERTO - VERTUOSO V1.0 SOFTWARE -SW002, CONEXUS ACTIVATOR 27901 (P980016/S062)Medtronic Cardiac Rhythm Disease Management2006-05-12
VENTAK P2 (P930035/S016)Boston Scientific2006-05-12
INSYNC FAMILIES OF CRT-ICDS (P010031/S033)Medtronic Cardiac Rhythm Disease Management2006-05-12
CONTAK RENEWAL CD (P010012/S126)Boston Scientific Corp2006-05-12
SMART CONTROL NITINOL STENT SYSTEM (P020036/S001)Cordis US Corporation2006-05-12
STELKAST SURPASS ACETABULAR SYSTEM (P040051)Stelkast Company2006-05-12
VENTAK (P830060/S060)Boston Scientific2006-05-12
SELUTE (P950001/S017)Boston Scientific2006-05-12
AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE, AMPLATZER DUCT OCCLUDER AND AMPLATZER DELIVERY AND EXCHANGE SYSTEM (P000039/S011)ABBOTT MEDICAL2006-05-12
VARIOUS FAMILIES OF PACEMAKERS (P990001/S023)Medtronic, Inc.2006-05-12
AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE, AMPLATZER DUCT OCCLUDER AND AMPLATZER DELIVERY AND EXCHANGE SYSTEM (P020024/S007)ABBOTT MEDICAL2006-05-12
VARIOUS FAMILIES OF ICDS (P980016/S064)Medtronic Cardiac Rhythm Disease Management2006-05-12
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM IPG/ETS 3.0 (P030017/S012)Boston Scientific Corp2006-05-12
VARIOUS FAMILIES OF PACEMAKERS MODELS KAPPA 700/600, 800/900, SIGMA AT 500, ENPULSE, ENRHYTHM (P980035/S052)Medtronic, Inc.2006-05-12
KAPPA 400 FAMILY OF PACEMAKERS (P970012/S020)Medtronic, Inc.2006-05-12
VENTAK PR/ VENTAK MINI (P910077/S060)Boston Scientific2006-05-12
RES-Q (P940008/S022)Boston Scientific2006-05-12
VARIOUS MODELS OF PACEMAKERS, MODELS SYMBIOS, SYNERGYST,SPECTRAX,PASYS (P820003/S076)Medtronic Cardiac Rhythm Disease Management2006-05-12
JEWEL AF, GEM III AT FAMILY OF ICDS (P980050/S020)Medtronic, Inc.2006-05-12
VARIOUS FAMILIES OF PACEMAKERS (P850051/S061)Medtronic, Inc.2006-05-12
SWEET TIP (P960006/S021)Boston Scientific2006-05-12
VIGOR (P940031/S053)Boston Scientific2006-05-12
VITALITY (P960040/S122)Boston Scientific2006-05-12
VARIOUS FAMILIES OF ICDS (P900061/S060)Medtronic Cardiac Rhythm Disease Management2006-05-12
ENDOTAK (P910073/S065)Boston Scientific2006-05-12
SWEET TIP RX/FLEXTEND (P960006/S020)Boston Scientific2006-05-11
SELUTE (P950001/S016)Boston Scientific2006-05-11
PROSORBA COLUMN (P850020/S023)Fresenius Hemocare, Inc.2006-05-11
ST JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S059)ABBOTT MEDICAL2006-05-11
THINLINE/FINELINE (P960004/S035)Boston Scientific2006-05-11
RES-Q (P940008/S021)Boston Scientific2006-05-11
CONVERT (MODEL V-191) AND CONVERT+ (MODEL V-195) SYSTEMS WITH APPLICATION SOFTWARE MODEL 3307 VERSION 4.9 (P910023/S081)ABBOTT MEDICAL2006-05-11
CONTAK CD/EASYTRAK (P010012/S125)Boston Scientific Corp2006-05-11
VENTAK PRX/MINI I-IV (P910077/S059)Boston Scientific2006-05-11
VENTAK AV/VR/PRIZM (P960040/S121)Boston Scientific2006-05-11
ENDOTAK/ENDURANCE/RELIANCE (P910073/S064)Boston Scientific2006-05-11
VENTAK P2 (P930035/S015)Boston Scientific2006-05-11
VENTAK (P830060/S059)Boston Scientific2006-05-11
UROVYSION BLADDER CANCER KIT (P030052/S001)Abbott Molecular2006-05-10
VYSIS PATH VYSION HER-2 DNA PROBE KIT (P980024/S002)Abbott Molecular, Inc.2006-05-10
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033)Smith & Nephew, Inc.2006-05-09
SELECTED FAMILIES OF ICD'S, ENTRUST FAMILY,INTRINSIC FAMILY,ONYX, MAXIMO FAMILY, MARQUIS FAMILY,GEM III FAMILY,GEM II FA (P980016/S072)Medtronic Cardiac Rhythm Disease Management2006-05-08
INSYNC FAMILIES OF CRT-ICD'S, INSYNC MAXIMO, INSYNC SENTRY FAMILY, INSYNC II PROTECT, INSYNC III MARQUIS FAMILY, INSYNC (P010031/S039)Medtronic Cardiac Rhythm Disease Management2006-05-08
VARIOUS FAMILIES OF ICD'S, GEM FAMILY, MICRO JEWEL II, MICRO JEWEL, JEWEL AND JEWEL PLUS FAMILY, PCD FAMILY,JEWEL CD 720 (P900061/S064)Medtronic Cardiac Rhythm Disease Management2006-05-08
VARIOUS FAMILIES OF PACEMAKERS, REAL PLUS & BOSS REVEAL PLUS PREVA FAMILY, VITATRON VISA, VITATRON LEGACY FAMILY, THERA (P890003/S103)Medtronic, Inc.2006-05-08
PRIZM/VITALITY (P960040/S104)Boston Scientific2006-05-05
CONTAK RENEWAL (P030005/S029)Guidant Corp.2006-05-05
NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL CATHETERS (P030031/S002)Biosense Webster, Inc.2006-05-05
RENEWAL (P010012/S099)Boston Scientific Corp2006-05-05
SENOGRAPHE DS FFDM SYSTEM (P990066/S023)GE Healthcare2006-05-05
NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S064)LivaNova USA, Inc.2006-05-04
VISX STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM (P930016/S024)Amo Manufacturing USA, LLC2006-05-03
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Every clearance here is in the API, with alerts when new ones post.