Atlas FDA

2005

743 FDA 510(k) clearances · PMA decision year

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◉ Watch 2005

RecordFirmDate
LT-CAGE LUMBAR TAPERED FUSION DEVICE (TI AND PEEK) (P970015/S030)Sofamor Danek2005-02-04
CEEON HEPARIN SURFACE MODIFIED UV-LIGHT ABSORBING ANTERIOR CHAMBER (IOLS) (P880070/S011)Abbott Medical Optics, Inc.2005-02-04
UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS) (P880081/S030)Johnson & Johnson Surgical Vision, Inc.2005-02-04
ANGIOJET RHEOLYTIC THROMBECTOMY CATHETER SYSTEM (P980037/S012)Boston Scientific Corp2005-02-04
TAPCATH AND TAPSCOPE DISPOSABLE TRANSESOPHAGEAL PROBES (P860008/S017)Cardio Command2005-02-03
TAPCATH AND TAPSCOPE DISPOSABLE TRANSESOPHAGEAL PROBES (P840002/S010)Cardiocommand, Inc.2005-02-03
CONTAK RENEWAL CRT-D MODEL H125 (P010012/S042)Boston Scientific Corp2005-02-02
THORATEC HEARTMATE XVE AND VE LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P920014/S024)Thoratec Corp2005-02-02
NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S055)LivaNova USA, Inc.2005-02-01
ESSURE SYSTEM (P020014/S008)Bayer Pharma AG2005-01-31
ABBOTT AXSYM ANTI-HCV (LIST NUMBER 5C36) (P970027/S004)Abbott Laboratories2005-01-31
BIOLON (1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY) (P960011/S009)Altacor , Ltd.2005-01-27
COLLAGRAFT STRIP BONE GRAFT MATRIX (P900039/S015)Neucoll, Inc.2005-01-24
UROVYSION BLADDER CANCER KIT (P030052)Abbott Molecular2005-01-24
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S004)Boston Scientific Corp2005-01-21
CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625 AND 6625 (P870056/S018)Edwards Lifesciences, LLC2005-01-19
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S005)Edwards Lifesciences, LLC2005-01-19
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S029)Cochlear Americas2005-01-19
CARPENTIER-SUPRANNULAR BIOPROSTHESIS MODEL 2650 (P010041/S005)Edwards Lifesciences, LLC2005-01-19
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS, MODELS 6625L AND 6625-ESR-LP (P870077/S016)Edwards Lifesciences, LLC2005-01-19
PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700,2700TFX,2800,2800TFX,3000,3000TFX,6900P PERIMOUNT PLUS AND 6900PTFX (P860057/S025)Edwards Lifesciences, LLC2005-01-19
CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM (P910023/S075)ABBOTT MEDICAL2005-01-19
THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD) (P870072/S030)Thoratec Laboratories Corp.2005-01-19
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM LEAD ASSEMBLY (P030017/S003)Boston Scientific Corp2005-01-19
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S004)Ortho-Clinical Diagnostics, Inc.2005-01-14
WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S018)Boston Scientific Scimed, Inc.2005-01-14
FRONTIER BIVENTRICULAR CARDIAC PACING SYSTEM (P030035/S002)ABBOTT MEDICAL2005-01-14
CROSSSAIL, OPENSAIL, RX CHASSIS I & III AND VOYAGER CORONARY DILATATION CATHETERS (P810046/S218)Advanced Cardiovascular Systems, Inc.2005-01-14
WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S012)Boston Scientific Corporation2005-01-14
ACTIVA PARKINSON'S CONTROL THERAPY (P960009/S030)Medtronic, Inc.2005-01-14
ST JUDE MEDICAL EPIC HF MODEL V-338 AND ATLAS + HF MODEL V-340 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) (P030054/S002)ABBOTT MEDICAL2005-01-14
IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR (P040014)Irvine Biomedical, Inc.2005-01-14
WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S023)Boston Scientific Corp2005-01-14
FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM (P890043/S038)Abbott Vascular2005-01-14
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S005)Coloplast Corp.2005-01-12
BLAZER II XP CARDIAC ABLATION CATHETERS (P020025/S008)Boston Scientific2005-01-10
BLAZER II CARDIAC ABLATION CATHETERS (P920047/S025)Boston Scientific Corp2005-01-10
FLUOROPERM 60 RIGID GAS PERMEABLE CONTACT LENSES (P870024/S045)CooperVision, Inc.2005-01-07
SURGIFOAM ABSORBABLE GELATIN SPONGE, U.S.P (P990004/S007)Ferrosan Meidcal Devices A/S2005-01-07
IMAGECHECKER D (P970058/S021)Hologic, Inc.2005-01-05
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORS (P030026/S003)Ortho-Clinical Diagnostics, Inc.2005-01-04
MENTOR POLYTEF PASTE FOR INJECTION (N16420/S007)Coloplast Corp.2005-01-03
GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S012)Gynecare, Inc.2005-01-03
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Every clearance here is in the API, with alerts when new ones post.