Atlas FDA

1999

547 FDA 510(k) clearances · PMA decision year

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◉ Watch 1999

RecordFirmDate
PROSTATRON PRAKTIS (P950014/S019)Urologix, Inc.1999-11-05
DELTA/VISTA PACEMAKERS (P910077/S029)Boston Scientific1999-11-05
VITEK 2 GRAM NEGATIVE AST FOR LEVOFLOXACIN (N50510/S098)Biomerieux Vitek, Inc.1999-11-05
DELTA/VISTA PACEMAKERS (P840068/S038)Boston Scientific1999-11-05
ENDOTRACHEAL TUBE CHANGERS (P800068/S002)Instrumentation Industries, Inc.1999-11-04
INTERSTIM CONTINENCE CONTROL SYSTEM (P970004/S006)Medtronic Neuromodulation1999-11-04
NIR PRIMO PREMOUNTED STENT DELIVERY SYSTEM (P980001/S013)Boston Scientific Corp1999-11-04
PTCA CATHETERS (P860019/S157)Scimed Life Systems, Inc.1999-11-03
THERMA CHOICE UTERINE BALLOON THERAPY SYSTEM (P970021/S002)Gynecare, Inc.1999-11-02
BAUSCH AND LOMB POLYMACON CONTACT LENSES (N16895/S086)Bausch & Lomb, Inc.1999-11-02
ACS OTW PHOTON CORONARY DILATATION CATHETER (P810046/S199)Advanced Cardiovascular Systems, Inc.1999-10-29
MEDTRONIC MODEL 8711 TWO PIECE INTRATHECAL CATHETER (P860004/S043)Medtronic, Inc.1999-10-29
RX5000 PROGRAMMER (P830026/S076)Boston Scientific1999-10-29
OMNISCIENCE CARDIAC VALVE (P830039/S010)Medical Cv, Inc.1999-10-29
LIPOSORBER LA-15 SYSTEM (P910018/S001)Kaneka Pharma America Corp.1999-10-29
ARROW INTERNATIONAL MODEL 3000/3000-16/3000-50 IMPLANTABLE INFUSION PUMPS (P890055/S011)Intera Oncology1999-10-25
PEPGEN P-15 (P990033)Ceramed Corp.1999-10-25
VASOSEAL (VASCULAR HEMOSTASIS DEVICE) (P920004/S011)St. Jude Medical, Inc.1999-10-22
CARPENTIER EDWARDS DURAFLEX BIOPROSTHESIS (P870077/S010)Edwards Lifesciences, LLC1999-10-22
CARPENTIER EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S012)Edwards Lifesciences, LLC1999-10-22
CARPENTIER EDWARDS BIOPROSTHESIS (P870056/S012)Edwards Lifesciences, LLC1999-10-22
DISCOVERY/MERIDIAN (P940031/S020)Boston Scientific1999-10-22
SVS APEX PLUS EXCIMER LASER WORKSTATION WITH THE EMPHASIS DISCS (P930034/S012)Alcon Laboratories, Inc.1999-10-21
SVS APEX PLUS EXCIMER LASER WORKSTATION (P930034/S013)Alcon Laboratories, Inc.1999-10-21
THIN LINE AND FINELINE PACING LEADS (P960004/S007)Boston Scientific1999-10-21
ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S045)ABBOTT MEDICAL1999-10-21
DISCOVERY/MERIDIAN PACEMAKER SYSTEMS (P940031/S021)Boston Scientific1999-10-20
ANCURE TUBE AND BIFURCATED SYSTEMS & ILIAC BALLOON CATHETER (P990017/S001)Boston Scientific Corp1999-10-20
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S029)Boston Scientific Corp1999-10-15
APLIGRAF(R) (GRAFTSKIN) (P950032/S014)Organogenesis, Inc.1999-10-14
CADENCE TIERED-THERAPYDEFIBRILLATOR SYSTEM (P910023/S044)ABBOTT MEDICAL1999-10-13
SIMPSON CORONARY ATHEROCATH-GTO (P890043/S034)Abbott Vascular1999-10-12
PERFLUORON (TM) (P950018/S003)Alcon Laboratories1999-10-12
LCS TOTAL KNEE SYSTEM (P830055/S065)Depuy, Inc.1999-10-07
VITEK 2 GRAM NEGATIVE AST FOR AMIKACIN (N50510/S094)Biomerieux Vitek, Inc.1999-10-07
LCS POSTERIOR STABILIZED TIBIAL INSERTS (P830055/S066)Depuy, Inc.1999-10-07
LIFE PULSE HIGH FREQUENCY VENTILATOR (P850064/S016)Bunnell, Inc.1999-10-05
IMAGE CHECKER M1000 (P970058/S005)Hologic, Inc.1999-10-05
LSC REVISION SYSTEM (P830055/S064)Depuy, Inc.1999-10-04
RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION (P950019/S008)Stryker Spine1999-10-04
MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM (P960009/S003)Medtronic, Inc.1999-09-30
GEN-PROBE(R) AMPLIFIED(TM) MYCOBACTERIUM TUBERCULOSIS DIRECT (MTD) TEST (P940034/S008)Gen-Probe, Inc.1999-09-30
SURGIFOAM ABSORBABLE GELATIN SPONGE, USP (P990004)Ferrosan Meidcal Devices A/S1999-09-30
SIMPSON CORONARY ATHEROCATH-SCA-EX, GTO AND BANTAM ATHERECTOMY CATHETERS (P890043/S033)Abbott Vascular1999-09-30
FEMSOFT URETHRAL INSERT (P990002)Rochester Medical Corp.1999-09-30
HANCOCK 1 STANDARD BIOPROSTHETIC VALVE (P870078/S005)Medtronic, Inc.1999-09-29
TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD/MONOCLONAL WHOLE BLOOD (P890025/S012)Abbott Laboratories1999-09-29
NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK) (P970053/S001)Nidek Co., Ltd.1999-09-29
HANCOCK MODIFIED ORIFICE, MODIFIED ORIFICE II AORTIC BIOPROSTHESES (P790007/S016)Medtronic Heart Valves1999-09-29
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S009)Medtronic, Inc.1999-09-29
MEDTRONIC HALL PROSTHETIC HEART VALVE, AORTIC VALVED CONDUIT, AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT (P790018/S035)Medtronic Cardiac Surgery1999-09-29
ENDOTAK FAMILY OF ENDOCARDIAL DEFIBRILLATION LEAD MODELS (P910073/S027)Boston Scientific1999-09-29
ANCURE(TM) TUBE SYSTEM, ANCURE(TM) BIFURCATED SYSTEM (P990017)Boston Scientific Corp1999-09-28
ANEURX STENT GRAFT SYSTEM (P990020)Medtronic Vascular1999-09-28
HANCOCK II PORCINE BIOPROSTHESIS (P980043)Medtronic, Inc.1999-09-28
APLIGRAF(R)(GRAFTSKIN) (P950032/S015)Organogenesis, Inc.1999-09-28
BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM (P970056)Technolas GmbH Perfect Vision1999-09-28
THINLINE/FINELINE (P960004/S008)Boston Scientific1999-09-27
DIVA PLATFORM IMPLANTABLE PULSE GENERATORS AND PRO VIT APPLICATION SOFTWARE VERSION 3.3.2 (P990001)Medtronic, Inc.1999-09-27
COOK MBC PTCA BALLOON DILATATION CATHETER (P990008)Cook, Inc.1999-09-27
CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S045)ABBOTT MEDICAL1999-09-27
LADARVISION EXCIMER LASER SYSTEM (P970043/S001)Alcon Laboratories1999-09-24
R5.111WE(REVISION OF R5.85WE) (P900070/S025)St. Jude Medical, Cardiac Rhythm Management Divisi1999-09-24
NETWORK PROGRAMMER (P880038/S035)St. Jude Medical, Inc.1999-09-24
RX5000 PROGRAMMER (P830026/S075)Boston Scientific1999-09-24
CARDIAC PACEMAKER PROGRAMMER & BASE STATION (P880086/S068)ABBOTT MEDICAL1999-09-24
LADAR VISION TREATMENTS (P970043/S004)Alcon Laboratories1999-09-24
NETWORK PROGRAMMER (P820018/S073)St. Jude Medical, Inc.1999-09-24
CARDIAC PACEMAKER PROGRAMMER & BASE STATION (P830045/S067)St. Jude Medical, Inc.1999-09-24
SOFTWARE MODEL 3264 REV A (P880006/S030)St. Jude Medical, Inc.1999-09-24
SPINALPAK(R) STIMULATOR (P850022/S009)Ahp Eos Buyer, Inc.1999-09-24
MEDTRONIC SPRINT FAMILY OF TRANSVENOUS DEFIBRILLATION LEADS (P920015/S016)Medtronic, Inc.1999-09-24
VITEK 2 GRAM NEGATIVE AST FOR CIPROFLOXACIN (N50510/S091)Biomerieux Vitek, Inc.1999-09-23
PORTACATH/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM (P900052/S008)Smiths Medical Asd, Inc.1999-09-23
ABBOTT IMX TACROLIMUS II (P970007/S001)Abbott Laboratories1999-09-22
ER-EIA MONOCLONAL (P850029/S002)Abbott Laboratories1999-09-22
PGR-EIA MONOCLONAL (P900013/S002)Abbott Laboratories1999-09-22
DEPUY 3 BONE CEMENT (P960001/S006)Depuy, Inc.1999-09-20
ACRYSOF SINGLE-PIECE FOLDABLE ACRYLIC POSTERIOR CHAMBER IOL (P930014/S006)Alcon Laboratories, Inc.1999-09-20
SCIMED RADIUS CORONARY STENT (P970061/S007)Boston Scientific Scimed, Inc.1999-09-17
ECLIPSE TMR HOLMIUM LASER SYSTEM (P970029/S001)Cryolife, Inc.1999-09-17
SHARP(X)TM NEEDLE DESTRUCTION UNIT (P980015/S003)Innovative Medical Systems, Inc.1999-09-17
UROLUME ENDOPROSTHESES (P920023/S009)Boston Scientific Corp1999-09-17
VITEK 2 GRAM NEGATIVE AST FOR TOBRAMYCIN (N50510/S090)Biomerieux Vitek, Inc.1999-09-17
TECHSTAR XL 6 FR. PERCUTANEOUS VASCULAR SURGICAL DEVICES (P960043/S020)Abbott Vascular, Inc.1999-09-16
BRIO CARDIAC PACEMAKERS (P950029/S007)MicroPort CRM USA, Inc.1999-09-16
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S026)Boston Scientific Corp1999-09-16
MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695 (P950024/S002)Medtronic, Inc.1999-09-16
DEFENDER II MODEL 9201 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P980049)MicroPort CRM USA, Inc.1999-09-15
ANGEION SENTINEL(TM) IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR(ICD)SYSTEM: REMOVAL OF PATIENT MONITORING REQUIREMENT (P970024/S003)MicroPort CRM USA, Inc.1999-09-14
GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER (P850049/S007)Cook, Inc.1999-09-14
CROSS FLEX LC BALLOON-EXPANDABLE STENT WITH OVER THE WIRE DELIVERY SYSTEM FOR CORONARY ARTERIES (P900043/S015)Cordis Corp.1999-09-14
DURASPHERE INJECTABLE BULKING AGENT (P980053)Carbon Medical Technologies, Inc.1999-09-13
PHYLAX 06 ICD/ACTIVE HOUSING/REPLACEMENT, MYCROPHYLAX/TMS 1000 TACHYARRHYTHMIA MONITORING SYSTEM (P980023/S002)Biotronik, Inc.1999-09-13
POLARITY PULSE GENERATOR MODELS 209K AND 2091M/S (P880086/S047)ABBOTT MEDICAL1999-09-13
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S021)Terumo Medical Corporation1999-09-10
ST AIA-PACK PA (P910065/S001)Tosoh Bioscience, Inc.1999-09-10
UVAR PHOTOPHORESIS SYSTEM (P860003/S030)Therakos Development Limited1999-09-07
INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S005)Medtronic Neuromodulation1999-09-03
SEPRAFILM BIORESORBABLE MEMBRANE (P950034/S013)Baxter Healthcare Corporation1999-09-03
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Track 1999 automatically

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