Atlas FDA

2000

570 FDA 510(k) clearances · PMA decision year

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◉ Watch 2000

RecordFirmDate
INTER FIX RP THREADED FUSION DEVICE (P970015/S005)Sofamor Danek2000-04-12
HEPATITIS C CHECK TESTING SERVICE (P980046/S002)Pwn Health Chicago, LLC2000-04-12
INTER FIX THREADED FUSION DEVICE (P970015/S008)Sofamor Danek2000-04-12
ACTIVA TREMOR CONTROL SYSTEM (P960009/S010)Medtronic, Inc.2000-04-12
ANEURX STENT GRAFT SYSTEM (P990020/S004)Medtronic Vascular2000-04-12
ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD,SQ PATCH LEAD, EPICARDIAL PATCHES (P910073/S031)Boston Scientific2000-04-11
ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD, SQ PATCH LEAD, EPICARDIAL PATCHES (P910077/S032)Boston Scientific2000-04-11
ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S043)Boston Scientific Corp2000-04-11
ELECTROMECHANICAL ENHANCEMENT TO DRIVER (P890057/S013)ZOLL Medical Corporation2000-04-11
VASOSEAL ES (ES DEVICE) (P920004/S012)St. Jude Medical, Inc.2000-04-10
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S041)Boston Scientific Corp2000-04-10
LUMBAR I/F CAGE WITH VSP SPINE SYSTEM (P960025/S003)Depuy Spine, Inc.2000-04-10
CROSSFLEX LC BALLOON EXPANDABLE STENT (ANGLED END/SQUARE END) WITH OVER THE WIRE DELIVERY SYSTEM (P900043/S019)Cordis Corp.2000-04-06
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S022)Terumo Medical Corporation2000-04-06
INTEGRITY AFX DR (MODEL 5342) & SR (MODEL 5142) PULSE GENERATORS (P880086/S070)ABBOTT MEDICAL2000-04-06
AFFINITY VDR MODEL 5430 PULSE GENERATOR (P880086/S071)ABBOTT MEDICAL2000-04-06
VITEK 2 GRAM NEGATIVE AST FOR AMPICILLIN (N50510/S127)Biomerieux Vitek, Inc.2000-04-05
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S042)Boston Scientific Corp2000-04-04
N (P980037/S001)Boston Scientific Corp2000-04-03
COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P990013)Starr Surgical Co.2000-04-02
ROTAGLIDE LUBRICANT STERILIZATION VESSEL CHANGE (P900056/S039)Boston Scientific Corp2000-04-01
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM FLOPPY GOLD GUIDE WIRE (P900056/S040)Boston Scientific Corp2000-04-01
VITEK 2 GRAM POSITIVE AST FOR AMPICILLIN/SULBACTAM (N50510/S125)Biomerieux Vitek, Inc.2000-03-31
VITEK(R) 2 GRAM POSITIVE AST FOR CEFAZOLIN (N50510/S126)Biomerieux Vitek, Inc.2000-03-31
RAY THREADED FUSION CAGE(TFC-TM) DEVICE WITH INSTRUMENTATION (P950019/S011)Stryker Spine2000-03-30
LCS TOTAL KNEE SYSTEM (P830055/S070)Depuy, Inc.2000-03-30
THINLINE ENDOCARDIAL PACING LEADS (P960004/S010)Boston Scientific2000-03-29
EVT ABDOMINAL AORTIC TUBE/EVT ABDOMINAL AORTIC BIF (P990017/S003)Boston Scientific Corp2000-03-29
POSTERIOR CHAMBER INTRAOCULAR LENSES (P970034/S005)Aaren Scientific2000-03-27
PTCA CATHETER (P860019/S159)Scimed Life Systems, Inc.2000-03-24
ANCURE ENDOGRAFT SYSTEM/ANCURE ILIAC BALLOON CATHETER (P990017/S005)Boston Scientific Corp2000-03-24
ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S038)Boston Scientific Corp2000-03-24
METHAFILCON A (P850079/S036)CooperVision, Inc.2000-03-23
SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES (P890040/S005)Unilens Corp., USA2000-03-23
ANGIO-SEAL (P930038/S024)Terumo Medical Corporation2000-03-23
MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT (P980009/S005)Boston Scientific Scimed, Inc.2000-03-23
SEPRAFILM BIORESORBABLE MEMBRANE (P950034/S014)Baxter Healthcare Corporation2000-03-23
ECLIPSE TMR HOLMIUN LASER SYSTEM (P970029/S003)Cryolife, Inc.2000-03-22
ITREL SPINAL CORD STIMULATION SYSTEM (P840001/S044)Medtronic Neuromodulation2000-03-21
ACTIVA TREMOR CONTROL SYSTEM (P960009/S009)Medtronic, Inc.2000-03-21
ACS MULTI-LINK DUET & TRISTAR CORONARY STENT SYSTEM (P970020/S020)Abbott Vascular, Inc.2000-03-20
VITEK 2 GRAM NEGATIVE AST FOR CEFTIZOXIME (N50510/S122)Biomerieux Vitek, Inc.2000-03-20
NIR PREMOUNTED STENT SYSTEMS (P980001/S012)Boston Scientific Corp2000-03-20
VITEK 2 GRAM NEGATIVE AST FOR NALIDIXIC ACID (N50510/S123)Biomerieux Vitek, Inc.2000-03-20
VITEK 2 GRAM NEGATIVE AST FOR AMOXICILLIN/CLAVULANIC ACID (N50510/S124)Biomerieux Vitek, Inc.2000-03-20
SPECTRANETICS LASER SHEATHS (SLS) (P960042/S005)Spectranetics (Philips)2000-03-17
POSSIS ANGIOJET(R) RHEOLYTIC(TM) THROMBECTOMY SYSTEM - CORONARY USE (P980037/S002)Boston Scientific Corp2000-03-17
ETHYLENE OXIDE (EO)STERILIZATION EQUIPMENT (P910001/S017)Spectranetics Corp.2000-03-17
INTACS CORNEAL RING SEGMENTS (P980031/S003)Addition Technology2000-03-17
CHILLI COOLED ABLATION SYSTEM (P990054)Boston Scientific Corp2000-03-17
NIR W/SOX PREMOUNTED STENT SYSTEM (P980001/S011)Boston Scientific Corp2000-03-16
TRANSCYTE (P960007/S013)Shire Regenerative Medicine2000-03-16
LCS(R) TOTAL KNEE SYSTEM DESIGN MODIFICATION TO ROTATING PLATFORM BEARINGS (P830055/S069)Depuy, Inc.2000-03-16
DIGENE HYBRID CAPTURE II HIGH-RISK HPV DNA TEST (P890064/S007)Qiagen Gaithersburg, Inc.2000-03-16
PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY (P900066/S003)Airgas Therapeutics, LLC2000-03-16
ABIOMED BVS 5000 BI-VENTRICULAR SUPPPORT SYSTEM (P900023/S030)Abiomed Cardiovascular, Inc.2000-03-13
CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER THERMOCOUPLE OR THERMISTOR (P950005/S007)Biosense Webster, Inc.2000-03-13
VENTAK PRX AICD SYSTEM (P910077/S030)Boston Scientific2000-03-10
SELUTE(R) STEROID-ELUTING LEAD (P950001/S005)Boston Scientific2000-03-10
ENDOTAK(R) TRANSVENOUS DEFIBRILLATION LEAD SYSTEM (P910073/S029)Boston Scientific2000-03-10
SWEET TIP RX STEROID ELUTING LEAD (P960006/S003)Boston Scientific2000-03-10
CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S003)Medtronic Minimed2000-03-10
VENTAK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P830060/S046)Boston Scientific2000-03-10
ORTHOLOGIC 1000-SC BONE GROWTH STIMULATOR (P910066/S014)Djo, LLC2000-03-09
VITEK 2 GRAM NEGATIVE AST FOR MEROPENEM (N50510/S121)Biomerieux Vitek, Inc.2000-03-09
INTERSTIM SYSTEM FOR URINARY CONTROL (P970004/S008)Medtronic Neuromodulation2000-03-09
PHYSIO STIM AND PHYSIO STIM LITE BONE GROWTH STIMULATORS (P850007/S020)Orthofix, Inc.2000-03-09
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S019)Terumo Medical Corporation2000-03-08
THE HEART LASER-TM CO2 TMR SYSTEM (THE HEART LASER) (P950015/S005)Laser Engineering Heart, Inc.2000-03-08
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S037)Boston Scientific Corp2000-03-08
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S036)Boston Scientific Corp2000-03-08
TENDRIL SDX (P960013/S007)ABBOTT MEDICAL2000-03-07
LCS TOTAL KNEE SYSTEM (P830055/S068)Depuy, Inc.2000-03-06
UVADEX(R) STERILE LIQUID (P860003/S033)Therakos Development Limited2000-03-06
AIA PACK PA (P910065/S002)Tosoh Bioscience, Inc.2000-03-03
CLOSER SUTURE MEDIATED CLOSURE DEVICE & ACCESSORIES (P960043/S021)Abbott Vascular, Inc.2000-03-02
RAY TFC DEVICE AND RAY TFC UNITE DEVICE (P950019/S009)Stryker Spine2000-03-02
GEM IMPLANTABLE CARDIOVERTER/ DEFIBRILLATOR (P900061/S041)Medtronic Cardiac Rhythm Disease Management2000-03-02
CROSSFLEX LC BALLOON EXPANDABLE STENT (ANGLED END/SQUARE END) WITH OVER THE WIRE DELIVERY SYSTEM (P900043/S022)Cordis Corp.2000-03-02
UROLOGIX TARGIS SYSTEM (P970008/S014)Urologix, LLC2000-03-02
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S023)Terumo Medical Corporation2000-03-01
INTERSTIM SYSTEM FOR URINARY CONTROL THERAPY (P970004/S007)Medtronic Neuromodulation2000-02-29
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) (N17600/S016)Davol Inc., Sub. C. R. Bard, Inc.2000-02-28
ST. JUDE MEDICAL MECHANICAL HEART VAVLE (P810002/S050)ABBOTT MEDICAL2000-02-28
NIR(TM) PREMOUNTED STENT SYSTEMS (P980001/S016)Boston Scientific Corp2000-02-25
CROSSFLEX LC BALLOON EXPANDABLE STENT WITH OTW DELIVERY SYSTEM (P900043/S018)Cordis Corp.2000-02-25
MODEL 6698 PATIENT TEST MAGNET (P940031/S022)Boston Scientific2000-02-25
TRANSPORTABLE MODEL STS-T LITHOTRIPTER (P870015/S035)Medstone Intl., Inc.2000-02-25
ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT (P970038/S004)Beckman Coulter, Inc.2000-02-24
CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE (P990023)Alcon Laboratories2000-02-24
ACCESS(R) HYBRITECH PSA ASSAY (P850048/S016)Beckman Coulter, Inc.2000-02-24
THINLINE/FINELINE ENDOCARDIAL PACING LEADS (P960004/S011)Boston Scientific2000-02-23
ANGIOPLASTY (PTCA) CATHETER (P860019/S158)Scimed Life Systems, Inc.2000-02-23
TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z) (P990027)Technolas Perfect Vision GmbH2000-02-23
FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S008)Medtronic, Inc.2000-02-23
ENDOTAK(R) TRANSVENOUS DEFIBRILLATION LEAD SYSTEM (P910073/S030)Boston Scientific2000-02-23
VENTAK(R) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P830060/S047)Boston Scientific2000-02-23
SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2000 (P900009/S006)Bioventus, LLC2000-02-22
TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO (P830045/S068)St. Jude Medical, Inc.2000-02-18
TRILOGY/SOLUS/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO (P880086/S069)ABBOTT MEDICAL2000-02-18
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Track 2000 automatically

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