Atlas FDA

1998

505 FDA 510(k) clearances · PMA decision year

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◉ Watch 1998

RecordFirmDate
UROLOGIC TARGIS SYSTEM (P970008/S007)Urologix, LLC1998-07-07
UROLUME(TM)ENDOPROSTHESIS (P920023/S005)Boston Scientific Corp1998-07-07
INTERTACH II MODELS 262-16 (P860007/S020)Boston Scientific1998-07-06
HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES (P850079/S029)CooperVision, Inc.1998-07-02
VANTAGE (TETRAFILCON A ) CONTACT LENS (N17679/S032)CooperVision, Inc.1998-07-02
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S032)Medtronic Cardiac Surgery1998-07-01
MICROSCAN(R) RAPID FLUOROGENIC PANELS (P870049/S027)Dade Intl., Inc.1998-06-30
ACS RX ROCKET CORONARY DILATION CATHETER (P810046/S188)Advanced Cardiovascular Systems, Inc.1998-06-29
PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM (P900043/S011)Cordis Corp.1998-06-29
SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S131)Scimed Life Systems, Inc.1998-06-29
VISCOAT(R) VISCOELASTIC SOLUTION (P840064/S021)Alcon Laboratories1998-06-29
ACS RX ESPRIT CORONARY DILATION CATHETER (P810046/S189)Advanced Cardiovascular Systems, Inc.1998-06-27
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S072)Cochlear Americas1998-06-26
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P890027/S040)Cochlear Americas1998-06-26
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P890027/S041)Cochlear Americas1998-06-26
ACHILLES EXPRESS ULTRASONOMETER (P970040)Ge Lunar Corp.1998-06-26
M1000 IMAGECHECKER (P970058)Hologic, Inc.1998-06-26
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S071)Cochlear Americas1998-06-26
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051)Cochlear Americas1998-06-25
PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM (P900043/S009)Cordis Corp.1998-06-24
GENESTONE 190 LITHOTRIPTER (P970062)Bmt, Inc.1998-06-24
DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM (P970044/S001)Dornier Medtech America, Inc.1998-06-23
CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) S-SERIES TM SPEECH PROCESSOR (P960058/S002)Advanced Bionics1998-06-22
DORNIER LITHOTRIPTER (STATIONARY AND MOBILE) (P840008/S063)Dornier Medtech America, Inc.1998-06-19
RAY TFC DEVICE WITH INSTRUMENTATION (20MM) (P950019/S003)Stryker Spine1998-06-17
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S003)Medtronic, Inc.1998-06-16
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S012)Terumo Medical Corporation1998-06-16
SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH 12 FRENCH OUTER SHEATH (P960042/S001)Spectranetics (Philips)1998-06-16
MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR (P890057/S010)ZOLL Medical Corporation1998-06-15
LOCATOR STEERABLE STYLET MODEL 4036 (P960013/S002)ABBOTT MEDICAL1998-06-15
BONNIE TM SLIDING RAIL PTCA CATHETERS (P880027/S055)Boston Scientific1998-06-15
CHAMPION WRAP PTCA CATHETER (P930012/S010)Progressive Angioplasty Systems, Inc.1998-06-15
VASOSEAL ANCHOR DEVICE (P920004/S009)St. Jude Medical, Inc.1998-06-12
ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR (P910066/S008)Djo, LLC1998-06-12
SULZER CARBOMEDICS CARBO-SEAL ASCENDING AORTIC PROSTHESIS (P900060/S017)Corcym S.r.l.1998-06-11
PROSTATRON (P950014/S014)Urologix, Inc.1998-06-09
ACS RX COMET VP (TM) CORONARY DILATATION CATHETER/HYDROCOAT HYDROPHILIC (P810046/S185)Advanced Cardiovascular Systems, Inc.1998-06-08
PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM (P900043/S008)Cordis Corp.1998-06-08
ATHEROCATH-BANTAM(TM) DIRECTIONAL CORONARY ATHERECTOMY SYSTEM (P890043/S032)Abbott Vascular1998-06-08
RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION (P950019/S002)Stryker Spine1998-06-08
DORNIER LITHOTRIPTER (STATIONARY AND MOBILE) (P840008/S064)Dornier Medtech America, Inc.1998-06-05
SVS APEX PLUS EXCIMER LASER WORKSTATION (P930034/S011)Alcon Laboratories, Inc.1998-06-04
TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S002)Stryker Corporation1998-06-04
TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S001)Stryker Corporation1998-06-04
SVS APEX PLUS EXCIMER LASER WORKSTATION (P910067/S003)Alcon Research, Ltd. Dba Alcon Laboratories, Inc.1998-06-04
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE (P930038/S010)Terumo Medical Corporation1998-06-03
SUREFIX TM MODEL 5072 LEAD (P930039/S004)Medtronic, Inc.1998-06-03
MEDTRONIC MODEL 5038 CAPSURE VDD-2 LEAD (P890003/S050)Medtronic, Inc.1998-06-03
CHARGER PTCA DILATATION CATHETERS (P880003/S072)Cordis Corp.1998-06-03
CAPSURE Z NOVUS/CAPSURE SP NOVUS TRANSVENOUS TINED PACING LEADS (P850089/S038)Medtronic Cardiac Rhythm Disease Management1998-06-01
FINISHED METHAFILCON A CONTACT LENSES (P890049/S004)Lombart Lenses, Ltd.1998-05-29
DERMAGRAFT-TC(TM) (P960007/S002)Shire Regenerative Medicine1998-05-29
DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM (P970044)Dornier Medtech America, Inc.1998-05-29
DERMAGRAFT-TC(TM) (P960007/S007)Shire Regenerative Medicine1998-05-29
MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN (P970026)Myriad Ultrasound Systems , Ltd.1998-05-29
DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY) (P840068/S035)Boston Scientific1998-05-28
CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE (P940022/S005)Advanced Bionics Corp.1998-05-28
MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS (P940031/S013)Boston Scientific1998-05-28
CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) FLEX LEAD ELECTRODE (P960058/S004)Advanced Bionics1998-05-28
ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S027)Abiomed Cardiovascular, Inc.1998-05-28
ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL (P960057)Wrightmedicaltechnologyinc1998-05-27
KONTRON KOLORMON PLUS BLOODGAS MODULE 7267505 (P810037/S010)Kontron Cardiovascular1998-05-22
APLIGRAF (GRAFTSKIN) (P950032)Organogenesis, Inc.1998-05-22
MEDTRONIC WIKTOR RIVAL CORONARY STENT SYSTEM (P960010/S001)Medtronics Interventional Vascular1998-05-21
COSMO, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS (P830026/S071)Boston Scientific1998-05-21
MEDTRONIC INDURA 1P ONE PIECE INTRATHECAL CATHETER (P860004/S039)Medtronic, Inc.1998-05-21
MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE (P890003/S056)Medtronic, Inc.1998-05-21
MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS (P970012/S001)Medtronic, Inc.1998-05-21
COSMOS, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS (P910020/S021)Boston Scientific1998-05-21
ECONOLITH(TM) LITHOTRIPTER (P950043/S004)Medispec, Ltd.1998-05-21
THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S005)Thoratec Laboratories Corp.1998-05-21
GUARDIAN CORONARY BALLOON DILATATION PTCA CATHETER (P970052/S002)Endologix, Inc.1998-05-19
USCI APOLLO RELY ADDITIONAL SIZES (P790017/S066)Medtronic, Ireland1998-05-18
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) (P940034/S004)Gen-Probe, Inc.1998-05-15
LCS TOTAL KNEE SYSTEM - ADDITION OF POSTERIOR STABILIZED FEMORAL AND BEARING COMPONENTS & RPII TIBIAL TRAYS & BEARING CO (P830055/S059)Depuy, Inc.1998-05-14
SPINAL-STIM LITE SPINAL FUSION SYSTEM (P850007/S021)Orthofix, Inc.1998-05-14
ACS RX ROCKET ACS AVENGER CORONARY DILATATION CATHETER (P810046/S183)Advanced Cardiovascular Systems, Inc.1998-05-14
DORNIER LITHOTRIPTER AND DORNIER COMPACT S LITHOTRIPTER (P840008/S062)Dornier Medtech America, Inc.1998-05-14
LCS TOTAL KNEE SYSTEM (P830055/S056)Depuy, Inc.1998-05-14
SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S142)Scimed Life Systems, Inc.1998-05-13
BAK INTERBODY FUSION SYSTEM (P950002/S006)Zimmer Spine, Inc.1998-05-12
IMX(R) HAVAB (P780012/S008)Abbott Laboratories1998-05-12
DERMAGRAFT-TC(TM) (P960007/S004)Shire Regenerative Medicine1998-05-12
IMMULITE PSA CATALOG # LKPS1,5) (P930027/S003)Siemens Healthcare Diagnostics, Inc.1998-05-08
APS II 3003 PROGRAMMER WITH MODEL 3203A FUNCTION PACK (P880006/S026)St. Jude Medical, Inc.1998-05-07
WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER (P950005/S001)Biosense Webster, Inc.1998-05-07
STAT-PACE II ESOPHAGEAL PACING SYSTEM (P840002/S008)Cardiocommand, Inc.1998-05-07
ECONOLITH(TM) LITHOTRIPTER (P950043/S002)Medispec, Ltd.1998-05-05
LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER) (P960019/S002)Laser Vision Centers, Inc.1998-05-05
GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG (P910030/S008)Cook, Inc.1998-05-05
AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM (P950009/S002)Bd Diagnostics1998-05-05
LCS TOTAL KNEE SYSTEM - ADDITION OF POSTERIOR STABILIZED FEMORAL AND BEARING COMPONENTS & RPII TIBIAL TRAYS & BEARING CO (P830055/S057)Depuy, Inc.1998-05-01
ORACLE MEGASONICS FIVE-64 PTCA CATHETER (P910031/S015)Abbott Vascular Devices1998-05-01
OSTEOGEN IMPLANTABLE SPINAL FUSION STIMULATOR (P790005/S040)Ahp Eos Buyer, Inc.1998-05-01
EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR (P850035/S023)Ahp Eos Buyer, Inc.1998-05-01
MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS (P940031/S011)Boston Scientific1998-04-30
SALEST TM SYSTEM (P970032)Hologic, Inc.1998-04-29
PRO OSTEON IMPLANT 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTE BLOCKS & GRANULES (P860005/S009)Interpore Intl.1998-04-28
ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM (P930029/S011)Medtronic, Inc.1998-04-20
UV-ELASTIC POSTERIOR CHAMBER IOL FOR LENS MODEL AA-4207VFHAMBER IOL'S (P880091/S012)Staar Surgical Co.1998-04-17
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Every clearance here is in the API, with alerts when new ones post.