Atlas FDA

2005

743 FDA 510(k) clearances · PMA decision year

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◉ Watch 2005

RecordFirmDate
HERCEPTEST (P980018/S003)Agilent Technologies Singapore (International) Pte , Ltd.2005-12-30
EXABLATE 2000 MRI GUIDED FOCUSED ULTRASOUND SYSTEM (P040003/S001)Insightec, Ltd.2005-12-30
HERCEP TEST (P980018/S005)Agilent Technologies Singapore (International) Pte , Ltd.2005-12-30
ENDOTAK RELIANCE G/SG LEADS (P910073/S061)Boston Scientific2005-12-30
HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S020)Integra LifeSciences Corporation2005-12-29
COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P810006/S023)Integra LifeSciences Corporation2005-12-29
INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S013)Integra Lifesciences Corp.2005-12-29
STELIX II ENDOCARDIAL PACING LEADS (P020030/S002)MicroPort CRM USA, Inc.2005-12-29
COLLACOTE ABSORABLE COLLAGEN WOUND DRESSING (P840062/S010)Integra Lifesciences Corp.2005-12-29
NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S062)LivaNova USA, Inc.2005-12-28
EPT 1000TC AND EPT 1000XP CARDIAC ABLATION SYSTEM (P020025/S014)Boston Scientific2005-12-23
SYNCHROMED IMPLANTABLE INFUSION SYSTEM (P860004/S075)Medtronic, Inc.2005-12-23
EPT 1000TC AND EPT 1000XP CARDIAC ABLATION SYSTEM (P920047/S030)Boston Scientific Corp2005-12-23
INTERSTIM-THERAPY FOR URINARY CONTROL (P970004/S035)Medtronic Neuromodulation2005-12-23
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S043)Advanced Bionics2005-12-23
DRIVER CORONARY STENT SYSTEM FAMILY OF PRODUCTS (P030009/S004)Medtronic, Ireland2005-12-22
VARIOUS MODELS OF PACEMAKERS (P820003/S075)Medtronic Cardiac Rhythm Disease Management2005-12-22
VARIOUS FAMILIES OF ICDS (P980016/S063)Medtronic Cardiac Rhythm Disease Management2005-12-22
KAPPA 400 FAMILY & PACEMAKERS (P970012/S019)Medtronic, Inc.2005-12-22
VARIOUS FAMILIES OF PACEMAKERS (P850051/S060)Medtronic, Inc.2005-12-22
INSYNC FAMILIES OF CRT-ICDS (P010031/S032)Medtronic Cardiac Rhythm Disease Management2005-12-22
VARIOUS FAMILIES OF PACEMAKERS (P980035/S051)Medtronic, Inc.2005-12-22
VARIOUS FAMILIES OF PACEMAKERS (P990001/S022)Medtronic, Inc.2005-12-22
VARIOUS FAMILIES OF ICD (P900061/S059)Medtronic Cardiac Rhythm Disease Management2005-12-22
VISIAN ICL (IMPLANTABLE COLLAMER LENS) (P030016)STAAR Surgical Company2005-12-22
INSYNC/INSYNC III CRT-IPGS (P010015/S018)Medtronic, Inc.2005-12-22
MEDTRONIC VASCULAR DRIVER RAPID EXCHANGE CORONARY STENT SYSTEM (P030009/S003)Medtronic, Ireland2005-12-22
JEWEL AF,GEM III AT FAMILY OF ICDS (P980050/S019)Medtronic, Inc.2005-12-22
LEGEND PLUS FAMILY OF PACEMAKERS (P930022/S002)Medtronic, Inc.2005-12-22
MEDTRONIC PACEMAKER SYSTEMS (P890003/S093)Medtronic, Inc.2005-12-22
DURALOC OPTION CERAMIC-ON-CERAMIC HIP SYSTEM (P040023/S003)DePuy Orthopaedics, Inc.2005-12-22
DISCOVERY, MERIDIAN (P940031/S045)Boston Scientific2005-12-21
GENESIS, GENESIS RC AND THE EON NEUROSTIMULATION SYSTEMS (P010032/S018)ABBOTT MEDICAL2005-12-21
STARCLOSE VASCULAR CLOSURE SYSTEM (P050007)Abbott Vascular Devices2005-12-21
CONTAK RENEWAL 3 (P010012/S077)Boston Scientific Corp2005-12-21
DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S030)Alcon Laboratories2005-12-21
ARRAY MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENS (P960028/S013)Johnson & Johnson Surgical Vision, Inc.2005-12-21
CONTAK RENEWAL TR (P030005/S021)Guidant Corp.2005-12-21
CYLOS FAMILY OF PULSE GENERATORS (P950037/S041)Biotronik, Inc.2005-12-21
LIBERTE CORONARY STENT SYSTEM (P040016/S007)Boston Scientific Scimed, Inc.2005-12-21
VITALITY HE FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S087)Boston Scientific2005-12-21
IBI THERAPY DUAL 8 ABLATION CATHETERS (P040042/S001)Irvine Biomedical,Inc.(Ibi)2005-12-21
GUIDANT ZOOM PROGRAMMER (P910077/S055)Boston Scientific2005-12-20
CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES (P010012/S084)Boston Scientific Corp2005-12-20
VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (P040045)Vistakon, Division of Johnson & Johnson Vision Car2005-12-20
CERALAS I LASER (P050021)Biolitec, Inc.2005-12-20
CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER(CRT-P) DEVICES (P030005/S027)Guidant Corp.2005-12-20
CONTAK RENEWAL (P010012/S080)Boston Scientific Corp2005-12-19
DISCOVERY/MERIDIAN (P940031/S047)Boston Scientific2005-12-19
CONTAK RENEWAL TR (P030005/S024)Guidant Corp.2005-12-19
PRIZM/VITALITY (P960040/S089)Boston Scientific2005-12-19
BIOSENSE WEBSTER NAVISTAR/ CELSIUS THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS (P030031/S001)Biosense Webster, Inc.2005-12-19
ADATO SIL-OL 5000 SILICONE OIL WITH SYRINGE (CATALOG NUMBER: ES 5000 S) (P910071/S007)Bausch & Lomb2005-12-16
CELSIUS RMT DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS, MODEL D-1249-02-S (P950005/S018)Biosense Webster, Inc.2005-12-16
ST.JUDE MEDICAL ICDS/CRT-DS (P030054/S011)ABBOTT MEDICAL2005-12-16
ST.JUDE MEDICAL ICDS/CRT-D (P910023/S080)ABBOTT MEDICAL2005-12-16
LIBERTE CORONARY STENT SYSTEM (P040016/S004)Boston Scientific Scimed, Inc.2005-12-16
C2 A-TAPER ACETABULAR SYSTEM (P050009)Biomet, Inc.2005-12-16
ACRYSOF TORIC SINGLE-PIECE NATURAL INTRAOCULAR LENS (IOL) MODELS SN60T3, SN60T4 AND SN60T5 (P930014/S016)Alcon Laboratories, Inc.2005-12-16
PTCA CATHETERS (P860019/S205)Scimed Life Systems, Inc.2005-12-15
ENDOTAK RELIANCE FAMILY OF LEADS (P910073/S060)Boston Scientific2005-12-15
GUIDANT VITALITY (P960040/S090)Boston Scientific2005-12-15
AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST (P940040/S006)Roche Molecular Systems, Inc.2005-12-14
ETI-HA-IGMK PLUS KIT (P890014/S008)DiaSorin, Inc.2005-12-14
DURASEAL DURAL SEALANT SYSTEM (P040034/S002)Integra LifeSciences Corporation2005-12-13
LCS UNI KNEE SYSTEM (P910016/S015)Depuy, Inc.2005-12-12
ETI-AB-HAVK PLUS (P890019/S012)Diasorin2005-12-12
DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM (P040023/S002)DePuy Orthopaedics, Inc.2005-12-12
CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S002)Ceramtec GmbH2005-12-12
LCS TOTAL KNEE SYSTEM (P830055/S093)Depuy, Inc.2005-12-12
DEFLUX (P000029/S013)Palette Life Sciences2005-12-12
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S011)Boston Scientific Corp2005-12-09
FLEXTEND FAMILY OF LEADS (P960006/S019)Boston Scientific2005-12-08
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR (P030024/S004)Ortho-Clinical Diagnostics2005-12-08
GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S002)W. L. Gore & Associates, Inc.2005-12-08
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR (P010021/S008)Ortho-Clinical Diagnostics, Inc.2005-12-08
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR (P000044/S010)Ortho-Clinical Diagnostics, Inc.2005-12-08
IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATOR (P000014/S013)Ortho-Clinical Diagnostics, Inc.2005-12-08
BIOGLUE SURGICAL ADHESIVE (P010003/S007)Cryolife, Inc.2005-12-08
VITROS IMMUNODIAGNOSTIC PRODICTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR (P030026/S009)Ortho-Clinical Diagnostics, Inc.2005-12-08
RELIANCE LEADS FLUORO RING (P910073/S059)Boston Scientific2005-12-08
IBI THERAPY ABLATION CATHETERS (P040014/S002)Irvine Biomedical, Inc.2005-12-08
VICTORY PULSE GENERATOR MODELS: XL DR 5816, DR 5810 AND SR 5610 (P880086/S108)ABBOTT MEDICAL2005-12-07
CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V) BIOPROSTHESIS,MODEL 2650 (P010041/S010)Edwards Lifesciences, LLC2005-12-06
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077/S021)Edwards Lifesciences, LLC2005-12-06
CARPENTIER-EDWARDS BIOPROSTHESIS,MODELS 2625 & 6625 (P870056/S023)Edwards Lifesciences, LLC2005-12-06
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2600P (P000007/S010)Edwards Lifesciences, LLC2005-12-06
MEDTRONIC ACTIVA DEEP BRAIN STIMULATION SYSTEMS (P960009/S035)Medtronic, Inc.2005-12-06
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S031)Edwards Lifesciences, LLC2005-12-06
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S048)Advanced Bionics2005-12-05
SEPRAFILM ADHESION BARRIER (P950034/S028)Baxter Healthcare Corporation2005-12-05
RENEWAL 3 RF ICDS (P910077/S054)Boston Scientific2005-12-02
MEDTRONIC SPRINT FIDELIS LEADS MODELS,6949,6948,6931,6930 (P920015/S032)Medtronic, Inc.2005-12-01
IMPLANTABLE NEUROSTIMULATOR (P960009/S034)Medtronic, Inc.2005-11-30
AIA-PACK PA PSA, ST AIA-PACK PA PSA (P910065/S006)Tosoh Bioscience, Inc.2005-11-30
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S007)W. L. Gore & Associates, Inc.2005-11-30
PROSTHETIC HEART VALVE (CPHV), CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) AND CARBO-SEAL VALSALVA ASCENDING AORTIC PRO (P900060/S034)Corcym S.r.l.2005-11-30
AMPLATZER DUCT OCCLUDER (P020024/S009)ABBOTT MEDICAL2005-11-30
GORE EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S014)W. L. Gore & Associates, Inc.2005-11-30
MEDTRONIC IMPLANTABLE NEUROSTIMULATOR (P840001/S086)Medtronic Neuromodulation2005-11-30
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Every clearance here is in the API, with alerts when new ones post.