Atlas FDA

2000

570 FDA 510(k) clearances · PMA decision year

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◉ Watch 2000

RecordFirmDate
TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ ADDVENT TEMPO (P900070/S026)St. Jude Medical, Cardiac Rhythm Management Divisi2000-02-18
VITEK 2 GRAM NEGATIVE AST FOR PIPERACILLIN/TAZOBACTAM (N50510/S119)Biomerieux Vitek, Inc.2000-02-17
NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S025)LivaNova USA, Inc.2000-02-16
ACS RX/OTW SOLARIS CORONARY DILATATION CATHETER (P810046/S200)Advanced Cardiovascular Systems, Inc.2000-02-16
ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S034)Boston Scientific Corp2000-02-16
VITEK 2 GRAM POSITIVE AST FOR OXACILLIN (N50510/S117)Biomerieux Vitek, Inc.2000-02-15
UROLUME(R) ENDOPROSTHESIS (P920023/S010)Boston Scientific Corp2000-02-14
ARTEGRAFT BOVINE HETEROGRAFT (N16837/S003)LeMaitre Vascular, Inc.2000-02-11
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S035)Boston Scientific Corp2000-02-11
RADIUS CORONARY STENT WITH DELIVERY SYSTEM (P970061/S008)Boston Scientific Scimed, Inc.2000-02-11
VITEK 2 GRAM NEGATIVE AST FOR CEFOXITIN (N50510/S118)Biomerieux Vitek, Inc.2000-02-10
UROLUME ENDOPROSTHESIS (P920023/S011)Boston Scientific Corp2000-02-09
HYSKON HYSTEROSCOPY FLUID (N17511/S013)Coopervision Surgical2000-02-09
SURGIFORM ABSORBABLE GELATION SPONGE, USP (P990004/S002)Ferrosan Meidcal Devices A/S2000-02-08
VITEK(R) GRAM POSITIVE AST FOR NITROFURANTOIN (N50510/S116)Biomerieux Vitek, Inc.2000-02-08
VITEK 2 GRAM POSITIVE AST FOR HIGH-LEVEL STREPTOMYCIN (N50510/S113)Biomerieux Vitek, Inc.2000-02-08
ANEURX STENT GRAFT SYSTEM (P990020/S002)Medtronic Vascular2000-02-08
ANEURX STENT GRAFT SYSTEM (P990020/S003)Medtronic Vascular2000-02-08
VITEK 2 GRAM NEGATIVE TETRACYCLINE (N50510/S115)Biomerieux Vitek, Inc.2000-02-08
POLYMETHYLMETHACRYLATE(PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (P960034/S001)Abbott Medical Optics, Inc.2000-02-07
VITEK 2 GRAM NEGATIVE NORFLOXACIN (N50510/S114)Biomerieux Vitek, Inc.2000-02-07
BOSTON EQUALENS(ITAFLUOROFOCON A)/EQUALENS II(OPRIFOCON A) (P860022/S052)Bausch & Lomb2000-02-04
PALMAZ-SCHATZ CROWN BALLOON EXPANDABLE STENT WITH POWERGRIP OVER-THE-WIRE DELIVERY SYSTEM (P900043/S021)Cordis Corp.2000-02-04
INFINITY LS EXCIMER LASER SYSTEM (P930034/S015)Alcon Laboratories, Inc.2000-02-03
SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P980040)Johnson & Johnson Surgical Vision, Inc.2000-02-03
MICRO-PACE DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER (P920032/S005)Pace Medical2000-02-02
PLATINUM SOUND PROCESSOR (COCHLEAR IMPLANT) (P940022/S013)Advanced Bionics Corp.2000-02-02
CLARION MULTI-STRATEGY COCHLEAR IMPLANT SYSTEM (P960058/S012)Advanced Bionics2000-02-02
CELLSIUS INTERFACE CABLES (AUTOCLAVABLE) (P950005/S006)Biosense Webster, Inc.2000-02-01
MAXXUM PTCA CATHETER (P860019/S156)Scimed Life Systems, Inc.2000-02-01
PALMAZ-SCHATZ MINICROWN BALLOON-EXPANDABLE STENT WITH HEPACOAT OVER THE WIRE DELIVERY SYSTEM FOR CORONARY ARTERIES (P900043/S017)Cordis Corp.2000-02-01
VITEK 2 GRAM NEGATIVE AST FOR TICARCILLIN (N50510/S112)Biomerieux Vitek, Inc.2000-02-01
VITEK 2 GRAM NEGATIVE AST FOR CEFPODOXIME (N50510/S120)Biomerieux Vitek, Inc.2000-02-01
VISIONS MADE WITH PARAGON HDS (PAFLUFOCON B) (P870024/S042)CooperVision, Inc.2000-01-31
VITEK(R) GRAM POSITIVE AST FOR NORFLOXACIN (N50510/S110)Biomerieux Vitek, Inc.2000-01-31
VITEK 2 GRAM POSITIVE AST FOR GENTAMICIN (N50510/S111)Biomerieux Vitek, Inc.2000-01-31
ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S032)Boston Scientific Corp2000-01-28
PALMAZ BALLOON EXPANDABLE STENTS (P890017/S007)Cordis US Corporation2000-01-28
CAPSUREZ NOVUS (P850089/S044)Medtronic Cardiac Rhythm Disease Management2000-01-28
CAPSURE Z/SP (P850089/S043)Medtronic Cardiac Rhythm Disease Management2000-01-28
3500/3510 PROGRAMMER (P830045/S066)St. Jude Medical, Inc.2000-01-28
REGENCY SC+, REGENCY SC, REGENCY SCX (P880006/S029)St. Jude Medical, Inc.2000-01-28
SUREFIX (P930039/S007)Medtronic, Inc.2000-01-28
3500/3510 PROGRAMMER (P880086/S067)ABBOTT MEDICAL2000-01-28
VITESSE-C OS CATHETER MODELS 114-009, 117-016, AND 120-009 (P910001/S014)Spectranetics Corp.2000-01-28
CAPSURE/CAPSURESP/NOVUS (P830061/S031)Medtronic Cardiac Rhythm Disease Management2000-01-28
GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066)GE Healthcare2000-01-28
CAPSUREFIX/SUREFIX (P930039/S008)Medtronic, Inc.2000-01-28
PEPGEN-P15 (P990033/S001)Ceramed Corp.2000-01-27
VITEK(R) 2 GRAM POSITIVE AST FOR HIGH-LEVEL GENTAMICIN (N50510/S108)Biomerieux Vitek, Inc.2000-01-24
CONSTANT FLOW IMPLANTABLE INFUSION PUMP (P890055/S009)Intera Oncology2000-01-21
VENTAK PRIZM DR/VR AICD (P960040/S012)Boston Scientific2000-01-21
VITEK 2 GRAM NEGATIVE AST FOR NITROFURANTOIN (N50510/S107)Biomerieux Vitek, Inc.2000-01-21
VENTRITEX SPL LEAD SYSTEM (P950022/S007)ABBOTT MEDICAL2000-01-20
THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER (P990035)Beam-Med, Ltd.2000-01-20
STYLET ACCESSORY KIT (P830060/S045)Boston Scientific2000-01-19
MATRITECH NMP22 TEST KIT (P940035/S002)Abbott Diagnostics Scarborough, Inc.2000-01-18
UVAR XTS PHOTOPHORESIS SYSTEM (P860003/S035)Therakos Development Limited2000-01-14
NEUROCONTROL FREEHAND SYSTEM (P950035/S005)Biocontrol Technology, Inc.2000-01-13
ANCURE TUBE AND BIFURCATED ENDOVASCULAR SYSTEMS (P990017/S002)Boston Scientific Corp2000-01-13
INTACS (INTRASTROMAL CORNEAL RING SEGMENTS) (P980031/S002)Addition Technology2000-01-12
HEART LASER(TM) CO2 TMR SYSTEM (P950015/S006)Laser Engineering Heart, Inc.2000-01-11
VITEK 2 GRAM POSITIVE AST FOR LEVOFLOXACIN (N50510/S106)Biomerieux Vitek, Inc.2000-01-10
LADAR VISION EXCIMER LASER SYSTEM (P970043/S006)Alcon Laboratories2000-01-07
MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0 (P990016)CooperSurgical, Inc.2000-01-07
THINELINE/FINELINE II ENDOCARDIAL PACING LEADS (P960004/S006)Boston Scientific2000-01-07
ANCURE(TM) ENDOGRAFT(R) SYSTEM (P990017/S004)Boston Scientific Corp2000-01-07
TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P880027/S056)Boston Scientific2000-01-07
ST JUDE TORONTO SPV VALVE (P970030/S003)St. Jude Medical, Inc.2000-01-06
VITEK 2 GRAM NEGATIVE AST FOR GENTAMICIN (N50510/S104)Biomerieux Vitek, Inc.2000-01-06
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Track 2000 automatically

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