Atlas FDA

1988

640 FDA 510(k) clearances · PMA decision year

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◉ Watch 1988

RecordFirmDate
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S015)Medtronic, Inc.1988-07-12
SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS (P820021/S010)Alcon Laboratories, Inc.1988-07-11
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S048)Advanced Cardiovascular Systems, Inc.1988-07-11
SENSITIVE EYES(TM) SALINE SOLUTION (P810039/S015)Bausch & Lomb, Inc.1988-07-07
DIASONICS NMR IMAGING SYSTEM (P830053/S029)Diasonics, Inc.1988-07-07
AUTOBAC MIC TEST SYSTEM (N50524/S025)Organon Teknika Corp.1988-07-07
NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI (P840024/S015)Cochlear Americas1988-07-07
CEA-ROCHE(R) EIA (P840027/S003)Roche Diagnostics GmbH1988-07-07
MODELS 925, 2040, 2041, 6564 (P840068/S005)Boston Scientific1988-07-07
BAUSCH & LOMB STERILE PRESERVED SALINE SOLN (P800024/S014)Bausch & Lomb, Inc.1988-07-06
B&L THERMA-ZYME, FIZZICLEAN (P850093/S007)Bausch & Lomb, Inc.1988-07-06
SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION (P820031/S009)Bausch & Lomb, Inc.1988-07-06
MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR (P850064)Bunnell, Inc.1988-06-30
THERAPEUTIC ULTRASOUND FOR TREATMENT OF GLAUCOMA (P860046)Sonocare, Inc.1988-06-30
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S016)General Electric Co.1988-06-30
UVAR PHOTOPHERESIS SYSTEM (P860003/S008)Therakos Development Limited1988-06-30
SPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER (P870043)Trimedyne, Inc.1988-06-30
OPUS - III CONTACT LENSES (P820074/S006)Wesley Jessen Corp.1988-06-29
BLAIREX STERILE SALINE SOLUTION (P850045/S010)Blairex Laboratories, Inc.1988-06-29
MODELS B-13F (P-10) & B-1H (P-11) (P810032/S017)Alcon Laboratories1988-06-29
MEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT (P870015/S001)Medstone Intl., Inc.1988-06-28
POLYQUAT DISINFECTION SYSTEM (P830034/S004)Alcon Laboratories1988-06-27
SCIMED PTCA DILATATION CATHETER (P860019/S010)Scimed Life Systems, Inc.1988-06-27
SCIMED PTCA DILATATION CATHETER (P860019/S011)Scimed Life Systems, Inc.1988-06-27
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S046)Advanced Cardiovascular Systems, Inc.1988-06-27
CLERZ LUBRICATING & REWETTING EYE DROPS (P800034/S010)Alcon Laboratories1988-06-27
MODELS PC10 & PC21 (P820049/S034)Advanced Medical Optics, Inc.1988-06-24
AUTOBAC MIC TEST SYSTEM (N50524/S026)Organon Teknika Corp.1988-06-22
AMER, ED. LABS. PTCA (P850021/S005)Abbott Vascular, Inc.1988-06-22
3M FLUOROPOLYMER CONTACT LENS (FLUROFOCON A) (P870009/S001)3M Company1988-06-21
SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS (P820021/S012)Alcon Laboratories, Inc.1988-06-21
BOSTON LENS(R) CLEANER (P820069/S011)Polymer Technology Corp.1988-06-21
BOSTON LENS(R) CONDITIONING SOLUTION (P820070/S013)Polymer Technology Corp.1988-06-21
ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7 (P860008/S002)Cardio Command1988-06-17
KESTREL NO. 695 HEATER (P820087/S011)Atrion Medical Products, Inc.1988-06-17
UVAR PHOTOPHERESIS SYSTEM (P860003/S007)Therakos Development Limited1988-06-17
PLIAGEL CLEANING SOLUTION FOR HYDROPHILIC(SOFT) CO (P800026/S005)Alcon Laboratories1988-06-16
MEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT (P870015/S002)Medstone Intl., Inc.1988-06-14
N.C.G.T. GRAFT (P800058/S006)St. Jude Medical, Inc.1988-06-14
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S004)Trimedyne, Inc.1988-06-14
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S018)Philips Medical Systems (Cleveland), Inc.1988-06-13
INSTRUMENTARIUM ULF MR IMAGING SYSTEM (P860010/S003)Palomex Instrumentarium Corp.1988-06-12
USCI GRUNTZIG DILACA CATHETER (P790017/S021)Medtronic, Ireland1988-06-09
MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS (P840040/S005)Boston Scientific Corp1988-06-09
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S019)Abbott Laboratories1988-06-08
TRESOFT SOFT CONTACT LENSE (N17855/S006)Ciba Vision Care1988-06-08
USCI GRUNTZIG DILACA CATHETER (P790017/S018)Medtronic, Ireland1988-06-07
WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS (P810005/S014)Ciba Vision Care1988-06-07
SURGILENE (N17825/S017)Davis & Geck, Inc.1988-06-06
AMER, ED. LABS. PTCA (P850021/S004)Abbott Vascular, Inc.1988-06-06
TANDEM(R)-E AFP (P840035/S007)Beckman Coulter, Inc.1988-06-03
MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S007)C.R. Bard, Inc.1988-06-01
FLUOROPERM RGP CONTACT LENSES (P870024/S002)CooperVision, Inc.1988-05-31
MODELS B-13F (P-10) & B-1H (P-11) (P810032/S015)Alcon Laboratories1988-05-26
AMVISC (R) (P810025/S010)Bausch & Lomb, Inc.1988-05-26
OCUSIL(TM) CONTACT LENS (P840050/S034)O.S.I. Corp.1988-05-26
POSTERIOR CHAMBER INTRAOCULAR LENSES (P810018/S024)Alcon Laboratories1988-05-26
APPLIED LABORATORIES STERILE SALINE SOLUTION (P870002/S001)Applied Laboratories, Inc.1988-05-25
UNISOL (P790011/S011)Wesley Jessen Corp.1988-05-25
MODEL 304 (ULTRA C-LOOP) (P860059/S006)Advanced Medical Optics, Inc.1988-05-25
PERMALENS EXTENDED WEAR CONTACT LENS (P780010/S015)CooperVision, Inc.1988-05-25
SAUFLON(R) PW (LIDOFILCON B) (P790020/S040)Advanced Medical Optics, Inc.1988-05-25
RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST (P860062/S001)Resonex, Inc.1988-05-25
MAGNETOM (P830081/S018)Siemens Corp.1988-05-24
FONAR NMR WHOLE BODY SCANNER BETA 3000 (P830076/S013)Fonar Corp.1988-05-24
LAMICEL(TM) (P820075/S004)Medtronic Xomed, Inc.1988-05-24
USCI GRUNTZIG DILACA CATHETER (P790017/S020)Medtronic, Ireland1988-05-24
SYSTEM COMPONENTS AND MODELS NUMBERS (P860004/S002)Medtronic, Inc.1988-05-24
MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS (P840040/S006)Boston Scientific Corp1988-05-24
PRENTIF TM CAVITY RIM CERVICAL CAP (P870062)Lamberts Dalston , Ltd.1988-05-23
HYDRON HYDROPHILIC CONTACT LENS (P780007/S026)CooperVision, Inc.1988-05-19
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S015)ABBOTT MEDICAL1988-05-18
SCIMED PTCA DILATATION CATHETER (P860019/S006)Scimed Life Systems, Inc.1988-05-18
SCIMED PTCA DILATATION CATHETER (P860019/S008)Scimed Life Systems, Inc.1988-05-18
SALITRON SYSTEM (P860067)Biosonics, Inc.1988-05-17
USCI GRUNTZIG DILACA CATHETER (P790017/S019)Medtronic, Ireland1988-05-17
DIPLOS MODEL 03 (P820076/S004)Biotronik, Inc.1988-05-17
NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI (P840024/S018)Cochlear Americas1988-05-16
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S017)Philips Medical Systems (Cleveland), Inc.1988-05-16
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S015)Philips Medical Systems (Cleveland), Inc.1988-05-16
FLEXLENS (N17976/S005)Paragon Vision Sciences1988-05-13
SOFT CONTACT LENS (N17987/S016)Ciba Vision Corporation1988-05-12
OSTEO CERAMIC HIP (P810048/S012)Smith & Nephew, Inc.1988-05-10
POLYCON CONTACT LENS (N18120/S019)Wesley Jessen Corp.1988-05-10
SGP LENS(TM) (P840055/S009)The Lifestyle Co., Inc.1988-05-10
LENS-WET(TM) (P800065/S010)Advanced Medical Optics, Inc.1988-05-10
QUASEPT II (N17679/S017)CooperVision, Inc.1988-05-10
HYDRASOFT (METHAFILCON A) CONTACT LENS (P850079/S008)CooperVision, Inc.1988-05-10
WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES (P800011/S009)Ciba Vision Corporation1988-05-10
SOFTHERM SOL. (N18078/S038)Advanced Medical Optics, Inc.1988-05-10
MODEL NO. ALS-IV HEAT DISINFECTION UNIT (P840054/S001)Abbott Medical Optics, Inc.1988-05-10
LENS FRESH(TM) LUBRICATING & REWETTING SOLN (N18020/S023)Advanced Medical Optics, Inc.1988-05-09
SM-1, CR-1, & GR-1 IOLS (P840060/S005)Alcon Laboratories1988-05-09
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S013)Medtronic Cardiac Surgery1988-05-09
STERIDYNE DYNASPRAY (P860050/S005)Optopics Laboratories Corp.1988-05-09
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S014)Medtronic Cardiac Surgery1988-05-09
CHAMBER LENS MODELS 101, 101B, 101T (P790027/S032)Bausch & Lomb1988-05-09
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S037)Medtronic Cardiac Rhythm Disease Management1988-05-09
KELMAN(TM) OMNIFIT II MODEL 2100 (P850059/S006)Bausch & Lomb Surgical, Inc.1988-05-09
PARAPERM O2 CONTACT LENS (P820063/S028)CooperVision, Inc.1988-05-09
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Every clearance here is in the API, with alerts when new ones post.