Atlas FDA

1999

547 FDA 510(k) clearances · PMA decision year

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◉ Watch 1999

RecordFirmDate
DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE AND TRANSPORTABLE/FS2000 X-RAY MODULE (P840008/S069)Dornier Medtech America, Inc.1999-09-02
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) (P940034/S007)Gen-Probe, Inc.1999-09-02
ELASTIC UVA PC IOL (P880091/S017)Staar Surgical Co.1999-09-02
THE IMAGECHECKER SYSTEM (P970058/S004)Hologic, Inc.1999-09-02
BIOLON 1% SODIUM HYALURONATE (P960011/S003)Altacor , Ltd.1999-09-02
EXTERNAL PULSE GENERATOR (P820003/S074)Medtronic Cardiac Rhythm Disease Management1999-09-01
DEPUY 1 AND ENDURANCE BONE CEMENTS (P960001/S008)Depuy, Inc.1999-09-01
ELASTIMIDE UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES (P880091/S016)Staar Surgical Co.1999-08-31
CSI (CROFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS (N17987/S026)Ciba Vision Corporation1999-08-30
SEPRAFILM BIORESORBABLE MEMBRANE (P950034/S012)Baxter Healthcare Corporation1999-08-27
ECONOLITH LITHOTRIPTER (P950043/S006)Medispec, Ltd.1999-08-27
PASSIVE PLUS DX ENDOCARDIAL, STEROID ELUTING, PASSIVE FIXATION PACING LEADS (P960030/S005)ABBOTT MEDICAL1999-08-26
SALEST SYSTEM (P970032/S001)Hologic, Inc.1999-08-26
DEPUY 3 BONE CEMENT (P960001/S005)Depuy, Inc.1999-08-26
SONIC ACCELERATED FRACTURE HEALING SYSTEM (P900009/S007)Bioventus, LLC1999-08-25
BRIO CARDIAC PACEMAKERS DUAL CHAMBER/DUAL CHAMBER RATE RESPONSIVE (P950029/S005)MicroPort CRM USA, Inc.1999-08-25
PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS (P980006/S001)Bausch & Lomb, Inc.1999-08-25
EMDOGAIN (P930021/S003)The Straumann Company1999-08-24
ACTROS+ FAMILY OF PULSE GENERATORS (P950037/S008)Biotronik, Inc.1999-08-24
GEMNOS & DROMOS SL PULSE GENERATORS (P820076/S022)Biotronik, Inc.1999-08-24
NECLEUS 24 COCHLEAR IMPLANT SYSTEM SOFTWARE (P970051/S007)Cochlear Americas1999-08-20
OPTIGUIDE CYLINDRICAL FIBER OPTIC (P940010/S007)Pinnacle Biologics, Inc.1999-08-13
BIOMEDICS 55 (OCUFILCON D) UV BLOCKER IMT SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR (P890023/S008)The Cooper Companies1999-08-13
ACS MULTI-LINK RX DUET/OTW DUET CORONARY STENT SYSTEM (P970020/S018)Abbott Vascular, Inc.1999-08-13
HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM (P940016/S004)B. Braun Avitum AG1999-08-12
MODEL 7271 GEM DR ICD (P980016/S007)Medtronic Cardiac Rhythm Disease Management1999-08-12
CAPSURE SP NOVUS MODEL 5092 (AND VITATRON EXCELLENCE SS+ MODEL IML 49B) (P850089/S042)Medtronic Cardiac Rhythm Disease Management1999-08-11
ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S004)Wrightmedicaltechnologyinc1999-08-11
VASOSEAL VHD (P920004/S010)St. Jude Medical, Inc.1999-08-10
HEARTMATE IP & VE LVAS (P920014/S009)Thoratec Corp1999-08-10
UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S031)Therakos Development Limited1999-08-10
MEDTRONIC SIGMA SERIES PULSE GENERATORS AND MODEL 9963/A SOFTWARE (P980035/S002)Medtronic, Inc.1999-08-09
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S028)Boston Scientific Corp1999-08-09
BIOTRIN PARVOVIRUS B19 IGG (P970054)Diasorin1999-08-06
BIOTRIN PARVOVIRUS IGM EIA (V619IMUS) (P970055)Diasorin1999-08-06
DERMAGRAFT-TC(TM) (P960007/S006)Shire Regenerative Medicine1999-08-05
LCS TOTAL KNEE SYSTEM (P830055/S063)Depuy, Inc.1999-08-05
VENTRITEX HOUSECALL RECEIVER/TRANSMITTER (P910023/S043)ABBOTT MEDICAL1999-08-04
ACTROS SLR+,KAIROS SL PULSE GENERATORS;SL 60-11,13,15 BP SINGLE PASS PACING LEAD;SWM 1000 B-G01.0.U (P950037/S007)Biotronik, Inc.1999-08-04
NIR ON RANGER PREMOUNTED STENT SYSTEMS (P980001/S002)Boston Scientific Corp1999-08-03
TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY (P850048/S015)Beckman Coulter, Inc.1999-08-03
SPECTRANETICS LASER SHEATH KITS, 14FR AND 16FR (P960042/S004)Spectranetics (Philips)1999-08-03
CEEON MODEL 912 FOLDABLE INTRAOCULAR LENS (P940007/S005)Advanced Medical Optics, Inc.1999-07-30
COSMAN ICP TELE-SENSOR(R) (P820012/S006)Integra Lifesciences Corp.1999-07-29
FREQUENCY 55 UV (SPHERICAL & TORIC ) SOFT CONTACT LENSES FOR EXTENDED WEAR (P850079/S031)CooperVision, Inc.1999-07-28
MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT (P980009/S002)Boston Scientific Scimed, Inc.1999-07-28
MASTERS SERIES COATED AORTIC VALVED GRAFT(MODEL CAVGJ-514) (P810002/S049)ABBOTT MEDICAL1999-07-28
AFFINITY/ENTITY DR,DC,SR (P880086/S066)ABBOTT MEDICAL1999-07-27
MEDTRONIC GEM II VR MODEL 7229 SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P980016/S003)Medtronic Cardiac Rhythm Disease Management1999-07-27
VITEK GRAM POSITIVE SUSCEPTIBILITY FOR OXACILLIN (N50510/S089)Biomerieux Vitek, Inc.1999-07-26
ORTHOPAK BONE GROWTH STIMULATOR (P850022/S012)Ahp Eos Buyer, Inc.1999-07-26
EMDOGAIN (P930021/S002)The Straumann Company1999-07-23
ENDOTRACHEAL TUBE CHANGER (P800068/S001)Instrumentation Industries, Inc.1999-07-23
ADDVENT/AV PLUS DX (P880086/S064)ABBOTT MEDICAL1999-07-23
NIR PREMOUNTED STENT SYSTEMS (P980001/S010)Boston Scientific Corp1999-07-22
LCS TOTAL KNEE SYSTEM (P830055/S062)Depuy, Inc.1999-07-22
D114S OVER-THE-WIRE BALLOON DILATATION CATHETER (P790017/S069)Medtronic, Ireland1999-07-22
3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03 (P830045/S065)St. Jude Medical, Inc.1999-07-21
3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03 (P880086/S063)ABBOTT MEDICAL1999-07-21
WALLSTENT TIPS ENDOPROSTHESIS (P930031/S006)Boston Scientific Corp1999-07-21
CLARION DEVICE FITTING SOFTWARE (SCLIN) (P960058/S010)Advanced Bionics1999-07-16
ABSORBO HP-ABSORBABLE DUSTING POWDER (N80535/S009)Ingredion Incorporated1999-07-16
NORIAN SRS CEMENT (P970010/S001)Synthes (Usa)1999-07-16
LAMICEL OSMOTIC CERVICAL DILATOR (P820075/S009)Medtronic Xomed, Inc.1999-07-16
LUMBAR I/F CAGE WITH VSP SPINAL SYSTEM (P960025/S001)Depuy Spine, Inc.1999-07-16
CLARION DEVICE FITTING SOFTWARE (SCLIN) (P940022/S011)Advanced Bionics Corp.1999-07-16
DEPUY 3 BONE CEMENT (P960001/S004)Depuy, Inc.1999-07-13
VITEK GRAM NEGATIVE SUSCEPTIBILITY CARD-CEFTRIAXONE (N50510/S088)Biomerieux Vitek, Inc.1999-07-12
VITEK 2 SYSTEM (N50510/S085)Biomerieux Vitek, Inc.1999-07-09
LAMICEL OSMOTIC CERVICAL DILATOR (P820075/S008)Medtronic Xomed, Inc.1999-07-09
VITEK GRAM NEGATIVE SUSCEPTIBILITY CARD-AMPICILLIN/SULBACTAM (N50510/S087)Biomerieux Vitek, Inc.1999-07-09
TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS (P980052)Stryker Leibinger, GmbH & Co KG1999-07-02
STAARVISC TM SODIUM HYALURONATE (P960033)Staar Sugical1999-07-02
SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES (P880081/S024)Johnson & Johnson Surgical Vision, Inc.1999-07-02
BIOLON TM (P960011/S002)Altacor , Ltd.1999-07-01
NIR PREMOUNTED STENT SYSTEMS (P980001/S009)Boston Scientific Corp1999-07-01
FINELINE (P960004/S005)Boston Scientific1999-07-01
SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM/31MM RADIUS OTW & 31 MM RADIUS SOE (P970061/S006)Boston Scientific Scimed, Inc.1999-06-30
MERIDEAN, DISCOVERY AND PULSAR PACEMAKERS (P940031/S019)Boston Scientific1999-06-29
VITEK 2 SYSTEM (N50510/S084)Biomerieux Vitek, Inc.1999-06-28
MEDTRONIC SYNCHROMED INFUSION SYSTEM (P860004/S037)Medtronic, Inc.1999-06-28
BAYER IMMUNO 1 SYSTEM (P950021/S001)Siemens Healthcare Diagnostics1999-06-25
VITEK 2 SYSTEM (N50510/S086)Biomerieux Vitek, Inc.1999-06-24
APLIGRAF (GRAFTSKIN) (P950032/S011)Organogenesis, Inc.1999-06-24
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S029)Dade Intl., Inc.1999-06-24
PRONOVA ABSORABLE SUTURE, USP (N16374/S036)ETHICON, Inc.1999-06-24
AFFINITY SR/DR (P880086/S062)ABBOTT MEDICAL1999-06-21
MEDSTONE STS-T LITHOTRIPTER (P870015/S033)Medstone Intl., Inc.1999-06-21
LIVEWIRE TC CARDIAC ABLATION SYSTEM-ADDITION OF LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY (P960016/S001)St Jude Medical1999-06-18
AFFINITY DR & DC; ENTITY DR & DC (P880086/S061)ABBOTT MEDICAL1999-06-17
BD PREPSTAIN SYSTEM (P970018)Bd Diagnostic Systems1999-06-17
TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY (P970038/S002)Beckman Coulter, Inc.1999-06-16
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S013)Beckman Coulter, Inc.1999-06-16
MEDTRONIC CAPSURE SP NOVUS MODEL 4092 VITATRON EXCELLENCE PS+ MODEL IMK 49B TRANVENOUS VENTRICULAR LEAD (P830061/S030)Medtronic Cardiac Rhythm Disease Management1999-06-16
TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY (P970038/S003)Beckman Coulter, Inc.1999-06-16
TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY (P850048/S014)Beckman Coulter, Inc.1999-06-16
VITEK 2 SYSTEM (N50510/S082)Biomerieux Vitek, Inc.1999-06-16
MEDTRONIC MODEL 7227CX GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P900061/S038)Medtronic Cardiac Rhythm Disease Management1999-06-16
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S027)Boston Scientific Corp1999-06-16
MEDTRONIC MODEL 7273 GEM II DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (P980016/S006)Medtronic Cardiac Rhythm Disease Management1999-06-16
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Track 1999 automatically

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