Atlas FDA

1999

547 FDA 510(k) clearances · PMA decision year

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◉ Watch 1999

RecordFirmDate
CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022)Medtronic Minimed1999-06-15
ENDOTAK ENDURANCE EZ ENDOCARDIAL DIFIBRILLATION LEAD (P910073/S026)Boston Scientific1999-06-15
CHILLI COOLED ABLATION SYSTEM (P980003/S001)Boston Scientific Corp1999-06-14
MEDTRONIC CAPSURE SP NOVUS (P850089/S041)Medtronic Cardiac Rhythm Disease Management1999-06-11
MEDTRONIC VISION SOFTWARE (MODEL 9953A) (P980035/S003)Medtronic, Inc.1999-06-11
NIR PRIMO PREMOUNTED STENT SYSTEM (P980001/S008)Boston Scientific Corp1999-06-11
TECHSTAR XL & PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM (P960043/S015)Abbott Vascular, Inc.1999-06-11
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S004)Cochlear Americas1999-06-09
AMO ARRAY MULTIFOCAL ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR (IOL) (P960028/S004)Johnson & Johnson Surgical Vision, Inc.1999-06-08
ACTROS DR+ -B PULSE GENERATOR (P950037/S009)Biotronik, Inc.1999-06-07
ACS OTW PHOTON CORONARY DILATATION CATHETER (P810046/S198)Advanced Cardiovascular Systems, Inc.1999-06-04
GFX SL OVER-THE-WIRE CORONARY STENT SYSTEM (P970035/S011)Medtronic, Ireland1999-06-03
PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (N970003)Boston Scientific Corp1999-06-03
ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S008)Wrightmedicaltechnologyinc1999-06-02
SULZER CARBOMEDICS CPHV OPTIFORM VALVE (P900060/S019)Corcym S.r.l.1999-06-01
TECHSTAR XL AND PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEM (P960043/S016)Abbott Vascular, Inc.1999-05-28
SCIMED REMEDY CORONARY BALLOON DILATATION INFUSION CATHETER (P860019/S149)Scimed Life Systems, Inc.1999-05-28
PALMAZ-SCHATZ MINICROWN BALLOON-EXPANDABLE STENT WITH DYNASTY OVER THE WIRE DELIVERY SYSTEM (P900043/S016)Cordis Corp.1999-05-27
ARROW INTERNATIONAL MODEL 3000/3000-16/3000-50 IMPLANTABLE (P890055/S010)Intera Oncology1999-05-27
SYNVISC (HYLAN G-F 20) (P940015/S004)Sanofi Genzyme Corp.1999-05-26
TECHSTAR XL & PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM (P960043/S018)Abbott Vascular, Inc.1999-05-26
GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (P940034/S010)Gen-Probe, Inc.1999-05-25
PRO OSTEON 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUE BLOCKS & GRANULES (P860005/S011)Interpore Intl.1999-05-25
INTERCEED*(TC7) ABSORBABLE ADHESION BARRIER (P880047/S007)ETHICON, Inc.1999-05-24
NIR PRIMO PREMOUNTED STENT SYSTEM (P980001/S001)Boston Scientific Corp1999-05-20
DURASOFT 3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILLIC) CONTACT LENSES (P830037/S041)Alcon Laboratories, Inc.1999-05-20
ACA MULTI-LINK & DUET CSS (P970020/S015)Abbott Vascular, Inc.1999-05-20
PROSTATRON (P950014/S018)Urologix, Inc.1999-05-19
ACS OTW SOLARIS CORONARY DILATATION CATHETER (P810046/S195)Advanced Cardiovascular Systems, Inc.1999-05-19
BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S029)Abiomed Cardiovascular, Inc.1999-05-19
LCS TOTAL KNEE SYSTEM-ADDITION OF ROTATING PLATFORM TIBIAL TRAY WITH KEEL (P830055/S061)Depuy, Inc.1999-05-19
NEUROCONTROL FREEHAND SYSTEM (P950035/S004)Biocontrol Technology, Inc.1999-05-18
BIORA EMDOGAIN(R) (P930021/S001)The Straumann Company1999-05-18
GFX 2 OVER-THE-WIRE CORONARY STSENT SYSTEM (P970035/S016)Medtronic, Ireland1999-05-14
NOVUS TM LC THREADED INTERBODY FUSION DEVICE (TIBFD) (P970015/S002)Sofamor Danek1999-05-14
INTER FIX THREADED FUSION DEVICE (P970015)Sofamor Danek1999-05-14
INTER FIX THREADED FUSION DEVICE (P970015/S003)Sofamor Danek1999-05-14
NOVUS (TM) LC INTERBODY FUSION DEVICE (P970015/S001)Sofamor Danek1999-05-14
ACS MULTI-LINK RX AND OTW DUET CORONARY STENT SYSTEM (P970020/S014)Abbott Vascular, Inc.1999-05-14
IOLAB BRAND UVBLOC PLUS(LC) UV-ABSORBING PMMA PC IOL'S (P790027/S064)Bausch & Lomb1999-05-13
POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES (P870013/S009)Bausch & Lomb1999-05-13
POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES (P790027/S060)Bausch & Lomb1999-05-13
IOLAB BRAND MODEL U85J UVBLOC PLUS (LC) UV-ABSORBING ONE-PIECE FLEXIBLE AC IOLS (P870013/S013)Bausch & Lomb1999-05-13
ADDVENT MODEL 2060LR PULSE GENERATOR AV PLUS SINGLE PASS LEAD MODEL 1328C (P880086/S038)ABBOTT MEDICAL1999-05-13
IOLAB BRAND MODEL 2192 KELMAN UVBLOC PLUS (LC) UV-ABSORBING PMMA AC IOLS (P850059/S021)Bausch & Lomb Surgical, Inc.1999-05-13
POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENS (P850059/S017)Bausch & Lomb Surgical, Inc.1999-05-13
PERMALENS (PERFILCON A) (P780010/S021)CooperVision, Inc.1999-05-12
LADAR VISION EXCIMER LASER SYSTEM (P970043/S003)Alcon Laboratories1999-05-12
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (2-METER INTRA-OPERATIIVE CABLE (P970051/S005)Cochlear Americas1999-05-12
MENTOR POSTERIOR CHAMBER INTRAOCULAR UV ABSORBING PMMA LENSES (P830056/S079)Carl Zeiss Meditec, AG1999-05-11
SCIMED PTCA CATHETERS (P860019/S153)Scimed Life Systems, Inc.1999-05-11
BIOMEDICS 55(OCUFILCON D) UV BLOCKING SOFT(HYDROPHILIC) CONTACT LENS(EXTENDED WEAR) (P890023/S007)The Cooper Companies1999-05-10
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S006)Cochlear Americas1999-05-07
FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL SOFT HYDROPHILIC CONTACT LENSES (P830037/S042)Alcon Laboratories, Inc.1999-05-07
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (ADULT) (P840024/S078)Cochlear Americas1999-05-07
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (CHILDREN) (P890027/S047)Cochlear Americas1999-05-07
DISCOVERY & MERIDIAN PULSE GENERATORS (P940031/S018)Boston Scientific1999-05-06
CHILLI COOLED ABLATION SYSTEM (P980003/S002)Boston Scientific Corp1999-05-06
ACS MULTI-LINK RX DUET & ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEMS (P970020/S011)Abbott Vascular, Inc.1999-05-06
INSTAT COLLAGEN ABSORBABLE HEMOSTAT (P830079/S012)ETHICON, Inc.1999-05-05
NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S022)LivaNova USA, Inc.1999-05-05
TECHSTAR AND TECHSTAR XL 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL SYSTEMS (P960043/S009)Abbott Vascular, Inc.1999-05-05
TECHSTAR XL & PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM (P960043/S017)Abbott Vascular, Inc.1999-05-05
INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S006)ETHICON, Inc.1999-05-05
SURGICEL, SURGICEL NU-KNIT FIBRILLAR ABSORBABLE HEMOSTAT (N12159/S017)ETHICON, Inc.1999-05-05
ACUVUE (ETAFILCON A) CONTACT LENS (N18033/S033)Vistakon, Johnson & Johnson Vision Products, Inc.1999-05-05
PERCLOSE PROSTAR XL 8 & 10 FRENCH PVS SYSTEM (P960043/S007)Abbott Vascular, Inc.1999-05-05
LIVEWIRE(R) CARDIAC ABLATION SYSTEM (P960016)St Jude Medical1999-05-04
VENTAK VR OMDEL 1774/MODEL 1775 AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH MODEL 2841 SOFTWARE APPLICATION (P960040/S009)Boston Scientific1999-05-03
UROLOGIX TARGIS SYSTEM (P970008/S011)Urologix, LLC1999-05-03
LITHOSTAR MULTILINE (P870018/S023)Siemens Corp.1999-04-30
HOLOGIC SAHARA CLINICAL BONE SONOMETER (P970017/S001)Hologic, Inc.1999-04-29
HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS (P980046)Pwn Health Chicago, LLC1999-04-28
PRO-TRAC II TACROLIMUS ELISA KIT (P970025)DiaSorin, Inc.1999-04-27
GFX & MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM (P970035/S006)Medtronic, Ireland1999-04-27
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S018)Terumo Medical Corporation1999-04-27
THE HEART LASER CO2 TMR SYSTEM (P950015/S002)Laser Engineering Heart, Inc.1999-04-27
HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM (P940016/S001)B. Braun Avitum AG1999-04-26
GELFOAM ABSORBABLE GELATIN POWDER (N18286/S011)Pfizer, Inc.1999-04-26
ACHILLES EXPRESS ULTRASONOMETER (P970040/S001)Ge Lunar Corp.1999-04-23
ACS MULTI-LINK RX DUET/OTW DUET CORONARY STENT SYSTEM (P970020/S012)Abbott Vascular, Inc.1999-04-22
MODEL 3510 PROGRAMMER/3303 SOFTWARE (P830045/S064)St. Jude Medical, Inc.1999-04-21
ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S006)Wrightmedicaltechnologyinc1999-04-21
MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER (P880065/S004)Boston Scientific Corp1999-04-21
MODEL 3510 PROGRAMMER/ 3303 SOFTWARE (P880086/S060)ABBOTT MEDICAL1999-04-21
SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM (P970061/S002)Boston Scientific Scimed, Inc.1999-04-21
PORT-A-CATH EPIDURAL/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM (P900052/S007)Smiths Medical Asd, Inc.1999-04-21
ORTHOLOGIC 1000 BONE GROWTH STIMULATOR/PATIENT REGISTRY MARKETING BROCHURE (P910066/S013)Djo, LLC1999-04-20
VENTRITEX CONTOUR II/MD; ANGSTROM II/MD; PROFILE II/MD TIERED THERAPY IMPLANTABLE DEFIBRILLATOR (P910023/S042)ABBOTT MEDICAL1999-04-19
VENTRITEX CONTOUR II/MD TIERED THERAPY IMPLANTABLE DEFIBRILLATOR (P910023/S041)ABBOTT MEDICAL1999-04-19
APLIGRAF TM (P950032/S009)Organogenesis, Inc.1999-04-19
PHYLAX ICD (P980023/S001)Biotronik, Inc.1999-04-19
UV-PMMA PCL'S (P970034/S003)Aaren Scientific1999-04-16
ST. JUDE MEDICAL MASTERS SERIES MECHANICAL HEART VALVE (P810002/S048)ABBOTT MEDICAL1999-04-16
T-SCAN 2000 (P970033)Mirabel Medical Systems, Inc.1999-04-16
PALMAZ-SCHATZ MINICROWN BALLOON-EXPANDABLE STENT WITH DYNASTY (P900043/S013)Cordis Corp.1999-04-15
GEM II DR MODEL 7273 (P980016/S005)Medtronic Cardiac Rhythm Disease Management1999-04-15
GEM MODEL 7227 CX ICD (P900061/S037)Medtronic Cardiac Rhythm Disease Management1999-04-15
METHAFILCON A (P850079/S030)CooperVision, Inc.1999-04-15
INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S004)Medtronic Neuromodulation1999-04-15
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Every clearance here is in the API, with alerts when new ones post.