Atlas FDA

1999

547 FDA 510(k) clearances · PMA decision year

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◉ Watch 1999

RecordFirmDate
EBI BONE HEALING SYSTEM-MODEL 1026 (P790002/S021)Ahp Eos Buyer, Inc.1999-12-29
REVEAL PLUS INSERTABLE LOOP RECORDER MODEL 9809 SOFTWARE (P890003/S058)Medtronic, Inc.1999-12-27
SPRINT LONG RANGE COIL (P970051/S009)Cochlear Americas1999-12-23
ESPRIT22 SPEECH PROCESSOR (P840024/S079)Cochlear Americas1999-12-23
CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE (P940022/S007)Advanced Bionics Corp.1999-12-23
ESPRIT22 SPEECH PROCESSOR (P890027/S048)Cochlear Americas1999-12-23
MODEL 7271 GEM DR ICD (P980016/S010)Medtronic Cardiac Rhythm Disease Management1999-12-23
MEDTRONIC VISION SOFTWARE (P970012/S009)Medtronic, Inc.1999-12-23
MEDTRONIC KAPPA 400/DX2 AND KAPPA 700/600 PACEMAKERS (P980035/S005)Medtronic, Inc.1999-12-23
S-ROM POLY-DAIL CONSTRAINED LINER (P960054/S003)Depuy, A Johnson & Johnson Co.1999-12-22
S540 OVER THE WIRE CORONARY STENT SYSTEM (P970035/S018)Medtronic, Ireland1999-12-22
ACS MULTI-LINK RX/OTW TRISTAR CORONARY STENT SYSTEM (P970020/S017)Abbott Vascular, Inc.1999-12-22
ACS MULTI-LINK RX DUET/OTW DUET CORONARY STENT SYSTEM (P970020/S019)Abbott Vascular, Inc.1999-12-22
NOVACOR LVAS (P980012/S001)Worldheart, Inc.1999-12-21
HEALON(R) SODIUM HYALURONATE (P810031/S022)Johnson & Johnson Surgical Vision, Inc.1999-12-21
BAK/L INTERBODY FUSION SYSTEM (P950002/S008)Zimmer Spine, Inc.1999-12-20
SYNVISC (HYLAN G-F 20) (P940015/S003)Sanofi Genzyme Corp.1999-12-20
MEDTRONIC.KAPPA 700/600 SERIES OF PACEMAKERS (P980035/S006)Medtronic, Inc.1999-12-20
HYALGAN(R) (P950027/S003)Fidia Farmaceutici S.P.A.1999-12-18
NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S024)LivaNova USA, Inc.1999-12-18
HYALGAN(R) (P950027/S002)Fidia Farmaceutici S.P.A.1999-12-18
ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR (P910066/S011)Djo, LLC1999-12-17
PROSORBA TREATMENT COLUMN FOR RA AND ITP (P850020/S012)Fresenius Hemocare, Inc.1999-12-17
ACTIVA TREMOR CONTROL THERAPY SYSTEM (P960009/S008)Medtronic, Inc.1999-12-17
LITHOTRON ULS (P970019/S006)Healthtronics Surgical Services, Inc.1999-12-17
SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS MODEL LI63U (P910056/S007)Bausch & Lomb, Inc.1999-12-16
DISHLER EXCIMER LASER SYSTEMS (P970049)Dtc Eye Surgery Center1999-12-16
TCI HEARTMATE(R) 1000A IP LVAD (P920014/S001)Thoratec Corp1999-12-16
BIOMEDICS 38 (POLYMACON) HYDROPHILIC CONTACT LENSES (P780007/S042)CooperVision, Inc.1999-12-14
BIOMEDICS 55 (OCUFILCON D) HYDROPHILIC CONTACT LENSES (P890023/S009)The Cooper Companies1999-12-14
LIVEWIRE TC CARDIAC ABLATION CATHETER (P960016/S003)St Jude Medical1999-12-13
GEM II IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR MODELS 7273 & 7229 (P980016/S012)Medtronic Cardiac Rhythm Disease Management1999-12-13
FLEX TIP PLUS INTRASPINAL CATHETER KIT(CATHETER CONNECTOR) (P890055/S008)Intera Oncology1999-12-10
VITEK 2 GRAM NEGATIVE AST FOR PIPERACILLIN (N50510/S096)Biomerieux Vitek, Inc.1999-12-10
ANEURX STENT GRAFT SYSTEM (P990020/S001)Medtronic Vascular1999-12-10
VITEK 2 GRAM POSITIVE AST FOR CIPROFLOXACIN (N50510/S102)Biomerieux Vitek, Inc.1999-12-10
ENUCLENE(R) OPHTHALMIC SOLUTION (N13787/S003)Alcon Research, Ltd.1999-12-10
VITEK(R) 2 GRAM POSITIVE AST FOR ERYTHROMYCIN (N50510/S101)Biomerieux Vitek, Inc.1999-12-10
HEARTMATE IP AND VE LVAS (P920014/S010)Thoratec Corp1999-12-10
CVX-300 EXCIMER LASER SYSTEM (P910001/S016)Spectranetics Corp.1999-12-10
MEDTRONIC 350 SERIES PACING SYSTEM (P980035/S004)Medtronic, Inc.1999-12-09
ARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRALOCULAR (P960028/S005)Johnson & Johnson Surgical Vision, Inc.1999-12-09
FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009)Baxter Healthcare Corp1999-12-08
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S020)Terumo Medical Corporation1999-12-08
S-ROM POLY-DIAL CONSTRAINED ACETABULAR LINER (P960054/S002)Depuy, A Johnson & Johnson Co.1999-12-07
UROLOGIX TARGIS SYSTEM (P970008/S012)Urologix, LLC1999-12-04
MULTI-PARTITION OPERATING ENVIRONMENT FOR ELA PROGRAMMERS (P950029/S008)MicroPort CRM USA, Inc.1999-12-03
LADAR VISION EXCIMER LASER SYSTEM (P970043/S002)Alcon Laboratories1999-12-03
MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS (P810055/S069)Advanced Medical Optics, Inc.1999-12-03
VITEX 2 GRAM NEGATIVE AST FOR AMPICILLIN/SULBACTAM (N50510/S097)Biomerieux Vitek, Inc.1999-12-03
BLU -U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR (P990019)Sun Pharmaceutical Industries, Inc.1999-12-03
IMPLANTABLE PACEMAKER LEADS (P910020/S024)Boston Scientific1999-12-02
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S031)Boston Scientific Corp1999-12-02
IMPLANTABLE PACEMAKER LEADS (P860007/S021)Boston Scientific1999-12-02
IMPLANTABLE PACEMAKER LEAD (P960004/S009)Boston Scientific1999-12-02
IMPLANTABLE PACEMAKER (P830026/S077)Boston Scientific1999-12-02
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S030)Boston Scientific Corp1999-12-02
SURGIFOAM ABSORBABLE GELATIN SPONGE, USP (P990004/S001)Ferrosan Meidcal Devices A/S1999-12-02
IMPLANTABLE PACEMAKER LEAD (P940008/S014)Boston Scientific1999-12-02
MEDTRONIC GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P900061/S036)Medtronic Cardiac Rhythm Disease Management1999-12-02
RAY THREADED FUSION CAGE(TFC) (P950019/S010)Stryker Spine1999-12-01
EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S013)Boston Scientific Corp1999-11-30
INTACS (INTRASTROMAL CORNEAL RING SEGMENTS) (P980031/S001)Addition Technology1999-11-29
UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S034)Therakos Development Limited1999-11-29
MAGIC WALLSTENT(R) SELF-EXPANDING CORONARY STENT (P980009/S004)Boston Scientific Scimed, Inc.1999-11-29
TRANSCYTE (P960007/S011)Shire Regenerative Medicine1999-11-26
METHAFILCON A SOFT HYDROPHILIC SPERICAL/TORIC CONTACT LENSES (P850079/S032)CooperVision, Inc.1999-11-24
ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S028)Abiomed Cardiovascular, Inc.1999-11-24
PURE VISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS (P980006/S002)Bausch & Lomb, Inc.1999-11-23
S670 RAPID EXCHANGE CORONARY STENT SYSTEM (P970035/S015)Medtronic, Ireland1999-11-23
INTEGRA ARTIFICIAL SKIN (P900033/S003)Integra Lifesciences Corp.1999-11-23
VENTRITEX TVL-ADX ACTIVE-FIXATION STEROID-ELUTING TACHYARRHYTHMIA LEAD (P950022/S006)ABBOTT MEDICAL1999-11-23
LCS TOTAL KNEE SYSTEM (P830055/S067)Depuy, Inc.1999-11-22
CLOSER PERCUTANEOUS VASCULAR SURGERY DEVICE (P960043/S019)Abbott Vascular, Inc.1999-11-22
TRANSPORTABLE MODEL STS-T LITHOTRIPTER (P870015/S034)Medstone Intl., Inc.1999-11-19
PROGRAMMING SOFTWARE UPGRADE (CSO 4.10 UG) (P950029/S009)MicroPort CRM USA, Inc.1999-11-19
DUAL CHANNEL ITREL SYNERGY NEUROSTIMULATION SYSTEM (P840001/S042)Medtronic Neuromodulation1999-11-19
VISX EXCIMER LASER SYSTEM MODEL C STAR (P990010)Amo Manufacturing USA, LLC1999-11-19
CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) (P960058/S011)Advanced Bionics1999-11-18
CSI (CROFILCON A) EXTENDED WEAR SOFT (N17987/S027)Ciba Vision Corporation1999-11-18
S670 OVER-THE-WIRE CORONARY STENT SYSTEM (P970035/S014)Medtronic, Ireland1999-11-16
LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER WITH UNIVERSAL TEMPERATURE MONITORING (P960016/S002)St Jude Medical1999-11-15
TS2000 (P970033/S001)Mirabel Medical Systems, Inc.1999-11-15
VITEK 2 GRAM POSITIVE AST FOR BENZYLPENICILLIN (N50510/S099)Biomerieux Vitek, Inc.1999-11-15
VITATRON DIVA IMPLANTABLE PULSE GENERATORS (P990001/S002)Medtronic, Inc.1999-11-12
LASERSCAN LSX EXCIMER LASER SYSTEM (P980008)Lasersight Technologies, Inc.1999-11-12
HYDROVIEW COMPOSITE HYDROGEL FOLDABLE UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P990014)Bausch & Lomb, Inc.1999-11-12
LCS TOTAL KNEE SYSTEM (P830055/S060)Depuy, Inc.1999-11-10
TENDRIL/PASSIVE PLUS/AV PLUS DX (P960030/S006)ABBOTT MEDICAL1999-11-10
VITEK 2 GRAM NEGATIVE AST FOR AZTRENAM (N50510/S093)Biomerieux Vitek, Inc.1999-11-10
VITATRON DIVA (P990001/S001)Medtronic, Inc.1999-11-10
TENDRIL/PASSIVE PLUS/AV PLUS DX (P960013/S006)ABBOTT MEDICAL1999-11-10
TENDRIL/PASSIVE PLUS/AV PLUS DX (P880086/S065)ABBOTT MEDICAL1999-11-10
S-ROM POLY-DIAL CONSTRAINED LINER (P960054/S004)Depuy, A Johnson & Johnson Co.1999-11-10
VITEK 2 ADVANCED EXPERT SYSTEM SOFTWARE (N50510/S103)Biomerieux Vitek, Inc.1999-11-10
HEART LASER CO2 TMR SYSTEM (P950015/S003)Laser Engineering Heart, Inc.1999-11-10
VITEK 2 GRAM NEGATIVE AST FOR CEFOTETAN (N50510/S095)Biomerieux Vitek, Inc.1999-11-08
AMO VITRAX (SODIUM HYALURONATE) VISCOELASTIC SOLUTION (P880031/S013)Abbott Medical Optics, Inc.1999-11-08
CLARION MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) (P940022/S012)Advanced Bionics Corp.1999-11-08
VITEK 2 GRAM NEGATIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE (N50510/S092)Biomerieux Vitek, Inc.1999-11-05
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Track 1999 automatically

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