Atlas FDA

2002

655 FDA 510(k) clearances · PMA decision year

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◉ Watch 2002

RecordFirmDate
CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS (P960036/S007)Ioltech, S.A.2002-07-26
CORDIS CHECKMATE SYSTEM (P990036/S003)Cordis Corp.2002-07-25
GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S013)Animas Corp.2002-07-25
MEDTRONIC ITREL SPINAL CORD STIMULATION SYSTEM (P840001/S062)Medtronic Neuromodulation2002-07-25
ENDOTAK RELIANCE/RELIANCE S STEROID ELUTING EXTENDABLE/RETRACTABLE HELIX ENDOCARDIAL DEFIBRILLATION LEAD (P910073/S039)Boston Scientific2002-07-25
HEALON SODIUM HYALURONATE (P810031/S024)Johnson & Johnson Surgical Vision, Inc.2002-07-25
ANCURE ENDOGRAFT SYSTEM (P990017/S032)Boston Scientific Corp2002-07-25
COBAS INTEGRA 400 PLUS CYCLOSPORINE (P920031/S003)Dade Behring, Inc.2002-07-24
DERMABOND TOPICAL SKIN ADHESIVE (P960052/S005)Closure Medical Corp.2002-07-24
IMMULITE 2000 XPI ANTI-HBC (P010051)Siemens Healthcare Diagnostics Products, Ltd.2002-07-24
MODELS S7, S670 AND S660 DISCRETE TECHNOLOGY OVER-THE-WIRE (P970035/S040)Medtronic, Ireland2002-07-24
ANCURE ENDOCRAFT SYSTEM (P990017/S034)Boston Scientific Corp2002-07-24
CAPSURE SENSE LEAD MODELS (P830061/S034)Medtronic Cardiac Rhythm Disease Management2002-07-23
IMMULITE 2000 XPI ANTI-HBS (P010052)Siemens Healthcare Diagnostics Products, Ltd.2002-07-22
SIEMENS SONOCUR BASIC SYSTEM (P010039)Siemens Medical Solutions USA, Inc.2002-07-19
ACS:180 & ADVIA CENTAUR CPSA IMMUNOASSAYS (P990055/S004)Siemens Healthcare Diagnostics2002-07-19
COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS (P020003)Coloplast Corp.2002-07-19
AMVISC/AMVISC PLUS SODIUM HYALURONATE (P810025/S020)Bausch & Lomb, Inc.2002-07-19
VENTAK PRIZM 2 VR/DR MODELS 1860/1861; VENTAK PRIZM VR/DR MODELS 1850/1851/1855/1856; VENTAK PRIZM VR/DR HE MODELS 1852 (P960040/S026)Boston Scientific2002-07-18
VENTAK PRIZM 2 VR/DR MODELS 1860/1861, VENTAK PRIZM VR/DR MODELS 1850/1851/1855/ (P910077/S037)Boston Scientific2002-07-18
CUTTING BALLOON (P950020/S005)Boston Scientific Corp2002-07-17
GENESIS XP & GENESIS DUAL XP NEUROSTIMULATION SYSTEMS (P010032/S002)ABBOTT MEDICAL2002-07-16
MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR (P990018/S002)Menicon Co, Ltd.2002-07-12
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S002)Med-El Corp.2002-07-11
PALMAZ BALLOON-EXPANDABLE STENT (P890017/S010)Cordis US Corporation2002-07-10
GYNECARE INTERGEL ADHESION PREVENTION SOLUTION (P990015/S001)Lifecore Biomedical, Inc.2002-07-09
FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES (P010019/S001)Alcon Laboratories, Inc.2002-07-05
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058)Medtronic Sofamor Danek USA, Inc.2002-07-02
VIBRANT SOUNDBRIDGE SYSTEM (P990052/S008)Med-El Elektromedizinische Gerate GmbH2002-07-02
APLIGRAF (P950032/S032)Organogenesis, Inc.2002-07-02
COLLAGRAFT STRIP BONE GRAFT MATRIX (P900039/S011)Neucoll, Inc.2002-07-02
BAUSCH AND LOMB HEFILCON A, B AND C HYDROPHILIC CONTACT LENSES (N17676/S028)Bausch & Lomb, Inc.2002-06-28
BAUSCH AND LOMB ELASTOFILCON A HYDROPHILIC CONTACT LENSES (P850068/S008)Bausch & Lomb, Inc.2002-06-28
CHILLI COOLED ABLATION SYSTEM (P990054/S004)Boston Scientific Corp2002-06-28
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S005)Covidien, LLC2002-06-28
INDERMIL TISSUE ADHESIVE (P010002/S002)Covidien Lp, Formerly Registered AS United States2002-06-28
BAUSCH AND LOMB LIDOFILCON A AND B HYDROPHILIC CONTACT LENSES (P880029/S015)Bausch & Lomb, Inc.2002-06-28
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WIRE (P900056/S074)Boston Scientific Corp2002-06-28
MULTI-LINK RX PIXEL/OTW PIXEL CORONARY STENT SYSTEM (P970020/S041)Abbott Vascular, Inc.2002-06-28
FLOSEAL MATRIX HEMOSTATIC SEALANT DEVICE (P990009/S012)Baxter Healthcare Corp2002-06-28
CHILLI COOLED ABLATION SYSTEM (P980003/S005)Boston Scientific Corp2002-06-28
BAUSCH AND LOMB POLYMACON HYDROPHILIC CONTACT LENSES (N16895/S088)Bausch & Lomb, Inc.2002-06-28
BAUSCH AND LOMB ALPHAFILCON A HYDROPHILIC CONTACT LENSES (P960022/S002)Bausch & Lomb, Inc.2002-06-28
BAUSCH AND LOMB BALAFILCON A HYDROPHILIC CONTACT LENSES (P980006/S003)Bausch & Lomb, Inc.2002-06-28
NOVOSTE/BETA-CATH SYSTEM (P000018/S022)Best Vascular, Inc.2002-06-28
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S072)Boston Scientific Corp2002-06-27
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S073)Boston Scientific Corp2002-06-26
CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031)Medtronic Cardiac Rhythm Disease Management2002-06-26
AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER (P880065/S007)Boston Scientific Corp2002-06-25
WALLSTENT VENOUS ENDOPROSTHESIS (P980033/S003)Boston Scientific Corporation2002-06-25
BOSTON SCIENTIFIC/SCIMED PTCA/PERFUSION CATHETERS (P860019/S185)Scimed Life Systems, Inc.2002-06-25
TMX-2000 BPH THERMOTHERAPY SYSTEM (P000043/S003)Boston Scientific Corp2002-06-25
PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) (P880027/S062)Boston Scientific2002-06-25
NIR PREMOUNTED STENT DELIVERY SYSTEMS (P980001/S040)Boston Scientific Corp2002-06-25
WALLSTENT TRANSJUGLAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) ENDOPROSTHESIS (P930031/S014)Boston Scientific Corp2002-06-25
RADIUS CORONARY STENT WITH DELIVERY SYSTEMS (P970061/S015)Boston Scientific Scimed, Inc.2002-06-25
MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S009)Medtronic Minimed2002-06-25
PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) (P860019/S184)Scimed Life Systems, Inc.2002-06-25
WALLSTENT ILLIAC ENDOPROSTHESIS (P940019/S012)Boston Scientific Scimed, Inc.2002-06-25
DIASORIN ETI-AB-AUK PLUS ASSAY (P990042/S003)DiaSorin, Inc.2002-06-24
CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC) (P010041)Edwards Lifesciences, LLC2002-06-24
INDERMIL TISSUE ADHESIVE (P010002/S001)Covidien Lp, Formerly Registered AS United States2002-06-20
CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS (P960036/S006)Ioltech, S.A.2002-06-20
VNS THERAPY SYSTEM (P970003/S040)LivaNova USA, Inc.2002-06-20
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH STYLET REPLACEMENT TOOL (P970051/S020)Cochlear Americas2002-06-20
CARDIOSEAL SEPTAL OCCLUSION SYSTEM W/QWIKLOAD (P000049/S004)Nmt Medical, Inc.2002-06-19
BAK/CERVICAL (BAK/C) (R) INTERBODY FUSION SYSTEM (P980048/S002)Sulzer Spine-Tech2002-06-19
NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S041)LivaNova USA, Inc.2002-06-18
NEUROCYBERNETIC PROSTHESES(NCP) SYSTEM (P970003/S039)LivaNova USA, Inc.2002-06-18
PEPGEN P-15 AND PEPGEN P-15 FLOW (P990033/S004)Ceramed Corp.2002-06-14
ALPHA I INFLATABLE PENILE PROSTHESIS (P000006/S001)Coloplast Corp.2002-06-14
WAVSTAT OPTICAL BIOPSY SYSTEM (P990050/S004)Spectra Science2002-06-14
AFFINITY (TM) CAGE SYSTEM (P000028)Medtronic Sofamor Danek USA, Inc.2002-06-13
FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENS) (P850079/S040)CooperVision, Inc.2002-06-13
QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM (P010049/S002)Sub-Q, Inc.2002-06-13
COSTASIS SURGICAL HEMOSTAT (P990030/S004)Angiotech Medical Device Technologies2002-06-13
SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S014)GE Healthcare2002-06-13
CORDIS CHECKMATE SYSTEM (P990036/S001)Cordis Corp.2002-06-13
PARAGON CRT (PAFLUFOCON B), PARAGON CRT 100 (PAFLUFOCON D), PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100.. (P870024/S043)CooperVision, Inc.2002-06-13
MODEL 9896 SOFTWARE FOR THE JEWEL MODEL 7218 (P890003/S069)Medtronic, Inc.2002-06-12
MODEL 9896 SOFTWARE FOR THE JEWEL MODEL 7218 (P900061/S052)Medtronic Cardiac Rhythm Disease Management2002-06-12
SHARPX NEEDLE DESTRUCTION UNIT (P980015/S005)Innovative Medical Systems, Inc.2002-06-12
ITREL 3, SYNERGY AND SYNDERGY VERSITREL NEUROSTIMULATORS (P840001/S063)Medtronic Neuromodulation2002-06-12
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S010)Smiths Medical Asd, Inc.2002-06-11
VASOSEAL 4-5 FRENCH SYSTEM (P920004/S017)St. Jude Medical, Inc.2002-06-11
MENTOR SALINE-FILLED/SPECTRUM MAMMARY PROSTHESES (P990075/S008)Mentor Worldwide, LLC2002-06-07
ATS OPEN PIVOT BILEAFLET AORTIC VALVED GRAFT (P990046/S005)Medtronic Ats Medical, Inc.2002-06-07
BTE (BEHIND-THE-EAR) SYSTEM SENSOR (ADULT) (P940022/S021)Advanced Bionics Corp.2002-06-06
CPI SWITCH BOX (P940022/S022)Advanced Bionics Corp.2002-06-06
BTE(BEHIND-THE-EAR)SYSTEM SENSOR (PEDIATRIC) (P960058/S022)Advanced Bionics2002-06-06
CLARION MULTI STRATEGY COCHLEAR IMPLANT SYSTEM (P960058/S021)Advanced Bionics2002-06-06
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM FOR ADULTS AND CHILDREN WITH CI 11=11=2M DOUBLE ARRAY COCHLEAR IMPLANT (P970051/S015)Cochlear Americas2002-06-06
GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S009)GE Healthcare2002-06-05
THE CLOSER S 6FR. SMC (P960043/S040)Abbott Vascular, Inc.2002-06-05
THINPREP PROCESSOR (MODEL TP-2000) (P950039/S008)Hologic, Inc.2002-06-05
GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S013)GE Healthcare2002-06-05
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S002)Hologic, Inc.2002-06-05
EMDOGAIN GEL (P930021/S005)The Straumann Company2002-06-04
MEDTRONIC INSYNC BIVENTRICULAR PACING SYSTEM (P010015/S004)Medtronic, Inc.2002-05-31
PRO OSTEON 500 BONE GRAFT SUBSTITUTE (P860005/S012)Interpore Intl.2002-05-31
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Every clearance here is in the API, with alerts when new ones post.