Atlas FDA

1989

625 FDA 510(k) clearances · PMA decision year

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◉ Watch 1989

RecordFirmDate
SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM (P840066/S018)Advanced Medical Optics, Inc.1989-08-23
SURGICEL (N12159/S011)ETHICON, Inc.1989-08-23
MODELS 019B, 019C, 019E, 019F, 019J, & 019K (P810055/S034)Advanced Medical Optics, Inc.1989-08-22
CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC (P820072/S022)Bausch & Lomb, Inc.1989-08-21
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S003)Beckman Coulter, Inc.1989-08-21
VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT (P880009/S002)Qiagen, Inc.1989-08-21
ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS (P880086)ABBOTT MEDICAL1989-08-21
J LOOP POSTERIOR CHAMBER TYPE II 0 & 10 (P840039/S006)Bausch & Lomb, Inc.1989-08-21
CHAMBER LENS MODELS 101, 101B, 101T (P790027/S034)Bausch & Lomb1989-08-18
STYLE UV40 POSTERIOR CHAMBER LENS (P830056/S042)Carl Zeiss Meditec, AG1989-08-18
STYLE 17 & 17A POSTERIOR CHAMBER IOLS (P830033/S015)Advanced Vision Science1989-08-18
MODELS U260,U360,U360N,U365,U370,&UP383 LENSES (P860059/S037)Advanced Medical Optics, Inc.1989-08-18
MODELS 019B, 019C, 019E, 019F, 019J, & 019K (P810055/S031)Advanced Medical Optics, Inc.1989-08-18
STYLE UV40 POSTERIOR CHAMBER LENS (P830056/S044)Carl Zeiss Meditec, AG1989-08-18
STYLE UV40 POSTERIOR CHAMBER LENS (P830056/S046)Carl Zeiss Meditec, AG1989-08-18
STYLE UV40 POSTERIOR CHAMBER LENS (P830056/S047)Carl Zeiss Meditec, AG1989-08-18
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S019)St. Jude Medical, Inc.1989-08-17
SOFLENS (N16895/S056)Bausch & Lomb, Inc.1989-08-17
C-65 DAILY CONTACT LENS CLEANER (P790024/S019)Advanced Medical Optics, Inc.1989-08-17
SOFLENS (N16895/S057)Bausch & Lomb, Inc.1989-08-17
INTRAOCULAR LENS MODELS C118;C119;C138 AND C139 (P880010/S003)Alcon Laboratories1989-08-17
AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL (P830060/S008)Boston Scientific1989-08-15
STYLE UV40 POSTERIOR CHAMBER LENS (P830056/S040)Carl Zeiss Meditec, AG1989-08-15
1CDELS B-13F (P-10) & B-1H (P-11) (P810032/S024)Alcon Laboratories1989-08-14
NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM (P830055/S013)Depuy, Inc.1989-08-14
MODELS B-13F (P-10) & B-1H (P-11) (P810032/S020)Alcon Laboratories1989-08-14
SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS (P820021/S015)Alcon Laboratories, Inc.1989-08-14
B&L THERMA-ZYME, FIZZICLEAN (P850093/S008)Bausch & Lomb, Inc.1989-08-11
QUASEPT II (N17679/S019)CooperVision, Inc.1989-08-11
CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE (P880079/S004)Ciba Vision Corporation1989-08-11
MODEL U58OH POSTERIOR CHAMBER LENS (P830056/S061)Carl Zeiss Meditec, AG1989-08-10
VITRAX SODIUM HYALURONATE (P880031)Abbott Medical Optics, Inc.1989-08-10
SM-1, CR-1, & GR-1 IOLS (P840060/S011)Alcon Laboratories1989-08-10
NON-PRESERVED SALINE SOLUTION (P850025/S007)Paco Pharmaceutical Services, Inc.1989-08-10
SM-1, CR-1, & GR-1 IOLS (P840060/S010)Alcon Laboratories1989-08-10
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S004)Beckman Coulter, Inc.1989-08-10
INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4 (P800036/S019)Intera Oncology1989-08-10
OPTI-CLEAN(TM) LC 1323 (P820036/S008)Alcon Laboratories1989-08-10
MODELS PC10 & PC21 (P820049/S046)Advanced Medical Optics, Inc.1989-08-10
MODELS PC10 & PC21 (P820049/S045)Advanced Medical Optics, Inc.1989-08-10
EBI BONE HEALING SYSTEM(R) (P790002/S011)Ahp Eos Buyer, Inc.1989-08-10
MODELS PC10 & PC21 (P820049/S047)Advanced Medical Optics, Inc.1989-08-10
SAUFLON(R) PW (LIDOFILCON B) (P790020/S044)Advanced Medical Optics, Inc.1989-08-08
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S015)Trimedyne, Inc.1989-08-08
WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS (P810005/S022)Ciba Vision Care1989-08-08
LITHOSTAR (P870018/S002)Siemens Corp.1989-08-08
INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4 (P800036/S018)Intera Oncology1989-08-08
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S032)St. Jude Medical, Inc.1989-08-08
NOVAFIL(TM) (P840041/S004)Davis & Geck, Inc.1989-08-08
GORE-TEX{TM} CRUCIATE LIGAMENT PROSTHESIS (P850074/S006)W. L. Gore & Associates, Inc.1989-08-03
SUPRAMID EXTRA SUTURES (N80838/S014)S. Jackson, Inc.1989-08-02
ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS (P840001/S015)Medtronic Neuromodulation1989-08-02
VISULAS ND:YAG LASER (P850083/S008)Carl Zeiss, Inc.1989-08-02
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S002)Dade Intl., Inc.1989-08-02
SILK SUTURES (N80989/S005)Lukens Corp.1989-08-01
ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS (P840001/S017)Medtronic Neuromodulation1989-08-01
UNISOL (P790011/S018)Wesley Jessen Corp.1989-08-01
STYLE 17 & 17A POSTERIOR CHAMBER IOLS (P830033/S009)Advanced Vision Science1989-08-01
STYLE 17 & 17A POSTERIOR CHAMBER IOLS (P830033/S010)Advanced Vision Science1989-08-01
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S006)Cook Pacemaker Corp.1989-07-31
IN A WINK CLEANING SOLUTION (P870005/S003)Ciba-Geigy Corp.1989-07-31
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S020)Medtronic, Inc.1989-07-31
META-MV,PACING SYSTEM (P880038/S002)St. Jude Medical, Inc.1989-07-27
NPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (P860040/S004)Wavetouch Technologies, LLC1989-07-27
FLUOREX (TM) 600 (FLURSILFOCON A) (P880001/S010)G.T. Laboratories, Inc.1989-07-25
GELFOAM (N18286/S003)Pfizer, Inc.1989-07-24
BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032)Bio-Rad1989-07-24
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S014)Trimedyne, Inc.1989-07-21
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S055)Advanced Cardiovascular Systems, Inc.1989-07-20
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S013)Trimedyne, Inc.1989-07-20
8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER (P870043/S006)Trimedyne, Inc.1989-07-20
TECHNOMED INTERNATIONAL SONOLITH 2000 (P880011/S001)Edap International Corp.1989-06-27
BOIL N SOAK CONTACT LENS FLUID (N17908/S042)Alcon Laboratories1989-06-26
SYNCHROMED(TM) INFUSION SYSTEM (P860004/S010)Medtronic, Inc.1989-06-26
SAUFLON(R) PW (LIDOFILCON B) (P790020/S046)Advanced Medical Optics, Inc.1989-06-26
PLIAGEL CLEANING SOLUTION FOR HYDROPHILIC(SOFT) CO (P800026/S007)Alcon Laboratories1989-06-26
HYDRON HYDROPHILIC CONTACT LENS (P780007/S033)CooperVision, Inc.1989-06-26
MODEL U58OH POSTERIOR CHAMBER LENS (P830056/S060)Carl Zeiss Meditec, AG1989-06-26
STYLE UV40 POSTERIOR CHAMBER LENS (P830056/S050)Carl Zeiss Meditec, AG1989-06-26
BLAIREX STERILE SALINE SOLUTION (P850045/S014)Blairex Laboratories, Inc.1989-06-26
SOFLENS (N16895/S058)Bausch & Lomb, Inc.1989-06-23
VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM (P870036/S005)Medtronics Interventional Vascular1989-06-23
SGP LENS(TM) (P840055/S012)The Lifestyle Co., Inc.1989-06-23
MICROSOFTRAC TM (PTCA) CATHETER (P880027/S001)Boston Scientific1989-06-23
FLUOROCON TM-60 (P890020)Ciba Vision Corporation1989-06-23
MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING (P830061/S008)Medtronic Cardiac Rhythm Disease Management1989-06-23
TECHNOMED INTERNATIONAL SONOLITH 2000 (P880011)Edap International Corp.1989-06-23
CLERZ LUBRICATING & REWETTING EYE DROPS (P800034/S012)Alcon Laboratories1989-06-22
COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS (P810057/S005)CooperVision, Inc.1989-06-22
STYLE UV40 POSTERIOR CHAMBER LENS (P830056/S033)Carl Zeiss Meditec, AG1989-06-20
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S004)Cook Pacemaker Corp.1989-06-20
VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM (P870036/S004)Medtronics Interventional Vascular1989-06-20
SOFT MATE COMFORT DROPS (P800018/S012)Advanced Medical Optics, Inc.1989-06-19
ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S008)Pacesetter Systems1989-06-19
NONABSORBABLE SURG. SUTURES, BRAIDED SILK (N84348/S006)Deknatel, Inc.1989-06-16
NONABSORBABLE SURG. SUTURES, NYLON (N85060/S007)Deknatel, Inc.1989-06-16
DEKLENE(TM) (P810028/S011)Deknatel, Inc.1989-06-16
PERMALENS EXTENDED WEAR CONTACT LENS (P780010/S016)CooperVision, Inc.1989-06-13
KELMAN(TM) OMNIFIT II MODEL 2100 (P850059/S005)Bausch & Lomb Surgical, Inc.1989-06-13
AUTOBAC MIC TEST SYSTEM (N50524/S032)Organon Teknika Corp.1989-06-13
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Every clearance here is in the API, with alerts when new ones post.