Atlas FDA

1989

625 FDA 510(k) clearances · PMA decision year

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◉ Watch 1989

RecordFirmDate
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S019)Trimedyne, Inc.1989-06-09
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S011)Trimedyne, Inc.1989-06-09
SUPRAMID EXTRA SUTURES (N80838/S015)S. Jackson, Inc.1989-06-08
MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S003)Davis & Geck, Inc.1989-06-07
USCI GRUNTZIG DILACA CATHETER (P790017/S026)Medtronic, Ireland1989-06-07
VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT (P880009/S001)Qiagen, Inc.1989-06-06
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S012)Trimedyne, Inc.1989-06-06
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S016)Trimedyne, Inc.1989-06-06
ALGES(TM) (HEFILCON A) CONTACT LENS (P850002/S005)Unilens Corp., USA1989-06-06
VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM (P870036/S003)Medtronics Interventional Vascular1989-06-06
8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER (P870043/S005)Trimedyne, Inc.1989-06-06
SENSITIVE EYES CLEANING/DISINFECTING SOLUTION (P860023/S004)Bausch & Lomb, Inc.1989-06-05
WET-N-SOAK (P870037/S004)Advanced Medical Optics, Inc.1989-06-05
POLYQUAT DISINFECTION SYSTEM (P830034/S006)Alcon Laboratories1989-06-05
TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS (P870079/S002)United Contact Lens, Inc.1989-06-02
ADAPETTES (N17945/S024)Alcon Laboratories1989-06-01
DURASOFT CONTACT LENS (N17852/S029)Wesley Jessen Corp.1989-06-01
UNISOL (P790011/S017)Wesley Jessen Corp.1989-06-01
POLYQUAT DISINFECTION SYSTEM (P830034/S008)Alcon Laboratories1989-06-01
BOSTON LENS(R) CONDITIONING SOLUTION (P820070/S014)Polymer Technology Corp.1989-06-01
CRYSTAL BLUE OPAQUE DURASOFT 3 HYDROPHILIC LENS (P830037/S024)Alcon Laboratories, Inc.1989-06-01
POLYPROPYLENE SURGICAL SUTURE (P890002)Alcon Laboratories1989-05-31
PARAPERM O2 CONTACT LENS (P820063/S039)CooperVision, Inc.1989-05-31
FLUOROPERM RGP CONTACT LENSES (P870024/S008)CooperVision, Inc.1989-05-31
PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN (P850038/S006)Paragon Optical Co.1989-05-31
DEXTRAN HM 32% (P880028)Hospira, Inc.1989-05-30
TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS (P870079/S001)United Contact Lens, Inc.1989-05-26
GORE-TEX(R) EXPANDED PTFE SUTURE (P820083/S010)W. L. Gore & Associates, Inc.1989-05-26
SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH (P820040/S020)Ciba Vision Care1989-05-26
SURGICEL (N12159/S010)ETHICON, Inc.1989-05-22
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S051)Advanced Cardiovascular Systems, Inc.1989-05-22
INTERTACH TM IMPLANTABLE PACEMAKER PULSE (P860007/S001)Boston Scientific1989-05-22
CMW BONE CEMENT (N18466/S007)Depuy, Inc.1989-05-19
NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S005)Datascope Corp.1989-05-17
PDS SUTURE (DYED) (N18331/S021)ETHICON, Inc.1989-05-17
META-MV,PACING SYSTEM (P880038/S001)St. Jude Medical, Inc.1989-05-10
SAUFLON(R) PW (LIDOFILCON B) (P790020/S043)Advanced Medical Optics, Inc.1989-05-10
ABBOTT AFP-EIA DIAGNOSTIC KIT FOR NTDS (P820060/S004)Abbott Laboratories1989-05-09
IGEL 67 CONTACT LENS (P860009/S002)Contamac, Ltd.1989-05-09
MODEL 304 (ULTRA C-LOOP) (P860059/S017)Advanced Medical Optics, Inc.1989-05-05
DURASOFT CONTACT LENS (N17852/S027)Wesley Jessen Corp.1989-05-05
COSMOS(TM) SYSTEM (P830026/S038)Boston Scientific1989-05-05
FLUOREX (TM) 600 (FLURSILFOCON A) (P880001/S013)G.T. Laboratories, Inc.1989-05-05
(MAFILCON) SOFT CONTACT LENSES (P800031/S001)N&N Menicon, Inc.1989-05-05
INTRAOCULAR LENS MODELS C118;C119;C138 AND C139 (P880010/S002)Alcon Laboratories1989-05-04
SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS (P820021/S016)Alcon Laboratories, Inc.1989-05-03
ALCON ENZYME CLEANER (P820001/S014)Alcon Laboratories1989-05-02
CRYSTAL BLUE OPAQUE DURASOFT 3 HYDROPHILIC LENS (P830037/S022)Alcon Laboratories, Inc.1989-05-02
LENS FRESH(TM) LUBRICATING & REWETTING SOLN (N18020/S027)Advanced Medical Optics, Inc.1989-05-02
BLAIREX STERILE SALINE SOLUTION (P850045/S011)Blairex Laboratories, Inc.1989-05-02
HYDRASOFT (METHAFILCON A) CONTACT LENS (P850079/S010)CooperVision, Inc.1989-05-02
GORE-TEX(R) EXPANDED PTFE SUTURE (P820083/S008)W. L. Gore & Associates, Inc.1989-05-02
GAS PERMEABLE REGIMEN (P820053/S011)Advanced Medical Optics, Inc.1989-05-02
POLYQUAT DISINFECTION SYSTEM (P830034/S005)Alcon Laboratories1989-05-02
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S010)Trimedyne, Inc.1989-05-01
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S018)St. Jude Medical, Inc.1989-05-01
TITRATOR{TM} MODEL 10K (P860035/S001)Ivac Corporation1989-05-01
CEA-ROCHE(R) EIA (P840027/S005)Roche Diagnostics GmbH1989-05-01
MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS (P840040/S010)Boston Scientific Corp1989-05-01
CEA-ROCHE(R) EIA (P840027/S006)Roche Diagnostics GmbH1989-05-01
NPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (P860040/S002)Wavetouch Technologies, LLC1989-05-01
MICROVEL(R) WITH HEMASHIELD (P840029)Maquet Cardiovascular, LLC1989-04-26
COOK BIRD'S NEST VENA CAVA FILTER (P850049)Cook, Inc.1989-04-26
MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING (P830061/S009)Medtronic Cardiac Rhythm Disease Management1989-04-26
MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525 (P850089/S011)Medtronic Cardiac Rhythm Disease Management1989-04-26
APPLIED LABORATORIES STERILE SALINE SOLUTION (P870002/S002)Applied Laboratories, Inc.1989-04-20
SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH (P820040/S023)Ciba Vision Care1989-04-20
MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525 (P850089/S010)Medtronic Cardiac Rhythm Disease Management1989-04-20
SOFLENS (N16895/S055)Bausch & Lomb, Inc.1989-04-20
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S009)Trimedyne, Inc.1989-04-19
8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER (P870043/S003)Trimedyne, Inc.1989-04-19
FLUOREX (TM) 600 (FLURSILFOCON A) (P880001/S009)G.T. Laboratories, Inc.1989-04-19
VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM (P870036/S002)Medtronics Interventional Vascular1989-04-19
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S041)Telectronics Pacing Systems, Inc.1989-04-18
FLUOREX (TM) 600 (FLURSILFOCON A) (P880001/S012)G.T. Laboratories, Inc.1989-04-18
ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7 (P860008/S007)Cardio Command1989-04-18
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S031)St. Jude Medical, Inc.1989-04-18
TELECTRONICS PASAR MODEL 4171 PG (P850027/S002)Telectronics, Inc.1989-04-18
PRIME{TM} MODEL 6520, 6525, 6530 AND 6535 (P870021/S002)Medtronic, Inc.1989-04-18
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S029)Telectronics Pacing Systems, Inc.1989-04-18
LITHOSTAR (P870018/S001)Siemens Corp.1989-04-18
MICROSOFTRAC TM (PTCA) CATHETER (P880027)Boston Scientific1989-04-14
COLLASTAT (P810006/S009)Integra LifeSciences Corporation1989-04-14
NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI (P840024/S020)Cochlear Americas1989-04-14
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S016)St. Jude Medical, Inc.1989-04-13
SYNERGYST PULSE GENERATORS MODEL 7026/7027 (P820003/S042)Medtronic Cardiac Rhythm Disease Management1989-04-13
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S017)St. Jude Medical, Inc.1989-04-13
SOFLENS (N16895/S059)Bausch & Lomb, Inc.1989-04-12
UVAR PHOTOPHERESIS SYSTEM (P860003/S011)Therakos Development Limited1989-04-12
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S040)Biomerieux Vitek, Inc.1989-04-12
THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS (P860022/S007)Bausch & Lomb1989-04-12
META-MV,PACING SYSTEM (P880038)St. Jude Medical, Inc.1989-04-07
LASTAC SYSTEM (P870071/S003)G V Medical, Inc.1989-04-06
LENS PLUS(TM) (P820050/S019)Advanced Medical Optics, Inc.1989-04-05
APPLIED LABORATORIES STERILE SALINE SOLUTION (P870002/S004)Applied Laboratories, Inc.1989-04-05
LASTAC SYSTEM (P870071/S002)G V Medical, Inc.1989-04-04
CORDIS PTCA DILATATION CATHETER (P880003/S003)Cordis Corp.1989-03-31
STORZ POSTERIOR CHAMBER INTRAOCULAR LENSES (P870073)Bausch & Lomb, Inc.1989-03-31
LASTAC SYSTEM (P870071/S005)G V Medical, Inc.1989-03-31
LASTAC SYSTEM (P870071/S004)G V Medical, Inc.1989-03-30
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Track 1989 automatically

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