Atlas FDA

1989

625 FDA 510(k) clearances · PMA decision year

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◉ Watch 1989

RecordFirmDate
PREFLEX DAILY CLEANING SOLN FOR SENSITIVE EYES (N17974/S044)Alcon Laboratories1989-03-29
MODEL 304 (ULTRA C-LOOP) (P860059/S016)Advanced Medical Optics, Inc.1989-03-29
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S001)Cook Pacemaker Corp.1989-03-29
BIAS(R) FIBER METAL TOTAL HIP SYSTEM (P850061/S001)Zimmer, Inc.1989-03-29
FLUOREX (TM) 600 (FLURSILFOCON A) (P880001/S002)G.T. Laboratories, Inc.1989-03-28
FLUOREX (TM) 600 (FLURSILFOCON A) (P880001/S011)G.T. Laboratories, Inc.1989-03-27
MODEL 304 (ULTRA C-LOOP) (P860059/S015)Advanced Medical Optics, Inc.1989-03-27
COOPERVISION PEROXIDE SYSTEM (P830023/S005)Alcon Laboratories1989-03-27
FLUOROPERM RGP CONTACT LENSES (P870024/S007)CooperVision, Inc.1989-03-27
PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN (P850038/S005)Paragon Optical Co.1989-03-27
AME BONE GROWTH STIMULATOR (P850007/S007)Orthofix, Inc.1989-03-24
ALGES(TM) (HEFILCON A) CONTACT LENS (P850002/S003)Unilens Corp., USA1989-03-23
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S002)Cook Pacemaker Corp.1989-03-22
SCIMED PTCA DILATATION CATHETER (P860019/S017)Scimed Life Systems, Inc.1989-03-20
SGP LENS(TM) (P840055/S013)The Lifestyle Co., Inc.1989-03-17
CHAMBER LENS MODELS 101, 101B, 101T (P790027/S033)Bausch & Lomb1989-03-17
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S001)Dade Intl., Inc.1989-03-16
MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR (P850064/S002)Bunnell, Inc.1989-03-15
THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS (P860022/S011)Bausch & Lomb1989-03-15
KONTUR SOFT (METHAFILCON A) LENS (P850078/S010)Kontur Kontact Lens Co., Inc.1989-03-14
B AND L 70 LIDOFILCON A CONTACT LENSE (P880029/S001)Bausch & Lomb, Inc.1989-03-13
SCIMED PTCA DILATATION CATHETER (P860019/S019)Scimed Life Systems, Inc.1989-03-13
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S021)Abbott Laboratories1989-03-10
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S015)St. Jude Medical, Inc.1989-03-09
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S053)Advanced Cardiovascular Systems, Inc.1989-03-09
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S054)Advanced Cardiovascular Systems, Inc.1989-03-09
NATUREVUE CONTACT LENSE (N17676/S018)Bausch & Lomb, Inc.1989-03-09
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S022)Abbott Laboratories1989-03-09
GORE-TEX(R) EXPANDED PTFE SUTURE (P820083/S009)W. L. Gore & Associates, Inc.1989-03-09
FLUOROPERM RGP CONTACT LENSES (P870024/S005)CooperVision, Inc.1989-03-09
NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S008)Datascope Corp.1989-03-09
GORE-TEX(R) EXPANDED PTFE SUTURE (P820083/S007)W. L. Gore & Associates, Inc.1989-03-09
ISOTONIC STERILE UNPRESERVED SALINE SOLUTION (P860066/S002)Visioncare Assoc.1989-03-03
METRO 55 (METHAFILCON A) (P830077/S002)Metrosoft, Inc.1989-03-02
CHAMBER LENS MODELS 101, 101B, 101T (P790027/S035)Bausch & Lomb1989-03-02
CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC (P820072/S023)Bausch & Lomb, Inc.1989-03-02
TENNANT(TM) & KELMAN(TM) TYPE II (P800016/S012)Bausch & Lomb, Inc.1989-03-02
SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH (P820040/S022)Ciba Vision Care1989-03-02
CELMAN(TM) OMNIFIT II MODEL 2100 (P850059/S007)Bausch & Lomb Surgical, Inc.1989-03-02
SAUFLON(R) PW (LIDOFILCON B) (P790020/S041)Advanced Medical Optics, Inc.1989-03-01
METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT (P820026/S005)Metrosoft, Inc.1989-03-01
DAVOL EXTERNALIZED EPIDURAL CATHETER (P860064/S002)C.R. Bard, Inc.1989-03-01
SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM (P880006)St. Jude Medical, Inc.1989-02-28
MODELS PC10 & PC21 (P820049/S037)Advanced Medical Optics, Inc.1989-02-27
MODEL AC10 & AC20 IOLS (P810056/S008)Advanced Medical Optics, Inc.1989-02-27
SCIMED PTCA DILATATION CATHETER (P860019/S018)Scimed Life Systems, Inc.1989-02-24
ORTHOPAK(R) BONE GROWTH STIMULATOR (P850022/S005)Ahp Eos Buyer, Inc.1989-02-24
DUPEN LONG TERM EPIDNRAL CATHETER (P860064/S001)C.R. Bard, Inc.1989-02-24
DIPLOS MODEL 03 (P820076/S006)Biotronik, Inc.1989-02-22
MODEL 304 (ULTRA C-LOOP) (P860059/S014)Advanced Medical Optics, Inc.1989-02-21
B&L 58(TM) (ETAFILCONA) CONTACT LENS (P850039/S004)Bausch & Lomb, Inc.1989-02-21
SCIMED PTCA DILATATION CATHETER (P860019/S016)Scimed Life Systems, Inc.1989-02-21
PARAPERM O2 CONTACT LENS (P820063/S038)CooperVision, Inc.1989-02-21
METRO 55 (METHAFILCON A) (P830077/S001)Metrosoft, Inc.1989-02-21
MODEL 304 (ULTRA C-LOOP) (P860059/S013)Advanced Medical Optics, Inc.1989-02-21
B AND L 70 LIDOFILCON A CONTACT LENSE (P880029/S003)Bausch & Lomb, Inc.1989-02-21
BOIL N SOAK CONTACT LENS FLUID (N17908/S041)Alcon Laboratories1989-02-21
OCUSIL(TM) CONTACT LENS (P840050/S041)O.S.I. Corp.1989-02-21
MODELS 925, 2040, 2041, 6564 (P840068/S006)Boston Scientific1989-02-21
OCUSIL(TM) CONTACT LENS (P840050/S040)O.S.I. Corp.1989-02-21
METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT (P820026/S003)Metrosoft, Inc.1989-02-21
MODEL 304 (ULTRA C-LOOP) (P860059/S011)Advanced Medical Optics, Inc.1989-02-21
CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC (P820072/S018)Bausch & Lomb, Inc.1989-02-16
MODEL AC10 & AC20 IOLS (P810056/S009)Advanced Medical Optics, Inc.1989-02-14
MODELS PC10 & PC21 (P820049/S039)Advanced Medical Optics, Inc.1989-02-14
SILSOFT (ELASTOFILCON A) CONTACT LENSES (P850068/S003)Bausch & Lomb, Inc.1989-02-10
MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING (P830061/S006)Medtronic Cardiac Rhythm Disease Management1989-02-10
FLUOREX (TM) 600 (FLURSILFOCON A) (P880001/S003)G.T. Laboratories, Inc.1989-02-10
FLUOREX (TM) 600 (FLURSILFOCON A) (P880001/S006)G.T. Laboratories, Inc.1989-02-09
FLUOREX (TM) 600 (FLURSILFOCON A) (P880001/S007)G.T. Laboratories, Inc.1989-02-09
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S006)Trimedyne, Inc.1989-02-09
FIBREL (P850053/S003)Mentor Corp.1989-02-09
HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE (P850010/S010)Integra LifeSciences Corporation1989-02-09
SOFLENS (N16895/S053)Bausch & Lomb, Inc.1989-02-09
COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS (P810057/S002)CooperVision, Inc.1989-02-08
SYNERGYST PULSE GENERATORS MODEL 7026/7027 (P820003/S040)Medtronic Cardiac Rhythm Disease Management1989-02-06
MODEL 304 (ULTRA C-LOOP) (P860059/S010)Advanced Medical Optics, Inc.1989-02-06
MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING (P830061/S007)Medtronic Cardiac Rhythm Disease Management1989-02-06
HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM (P830018)Organon Teknika Corp.1989-02-06
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR (P830070/S031)Ciba Vision Corporation1989-02-06
SYNERGYST PULSE GENERATORS MODEL 7026/7027 (P820003/S041)Medtronic Cardiac Rhythm Disease Management1989-02-06
MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525 (P850089/S008)Medtronic Cardiac Rhythm Disease Management1989-02-03
SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH (P820040/S007)Ciba Vision Care1989-02-02
DEKLENE(TM) (P810028/S010)Deknatel, Inc.1989-02-02
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S050)Advanced Cardiovascular Systems, Inc.1989-02-02
SYNCHROMED(TM) INFUSION SYSTEM (P860004/S008)Medtronic, Inc.1989-02-02
SYNCHROMED(TM) INFUSION SYSTEM (P860004/S007)Medtronic, Inc.1989-02-02
MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR (P850064/S001)Bunnell, Inc.1989-02-02
LASTAC SYSTEM (P870071/S001)G V Medical, Inc.1989-02-02
AMER, ED. LABS. PTCA (P850021/S006)Abbott Vascular, Inc.1989-02-02
SYNCHROMED(TM) INFUSION SYSTEM (P860004/S006)Medtronic, Inc.1989-02-02
NONABSORBABLE SURG. SUTURES, NYLON (N85060/S005)Deknatel, Inc.1989-01-31
DEKLENE(TM) (P810028/S008)Deknatel, Inc.1989-01-31
CHROMIC GUT SUTURE (N84381/S007)Deknatel, Inc.1989-01-31
MODEL 304 (ULTRA C-LOOP) (P860059/S005)Advanced Medical Optics, Inc.1989-01-31
NONABSORBABLE SURG. SUTURES, BRAIDED SILK (N84348/S004)Deknatel, Inc.1989-01-31
PLAIN GUT SUTURES (N84380/S007)Deknatel, Inc.1989-01-31
SUPERSTAT (P810040/S006)Superstat Corp.1989-01-30
PALACOS R BONE CEMENT (P810020/S002)Smith & Nephew Richards, Inc.1989-01-30
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S052)Advanced Cardiovascular Systems, Inc.1989-01-27
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