Atlas FDA

1987

546 FDA 510(k) clearances · PMA decision year

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◉ Watch 1987

RecordFirmDate
BLAIREX STERILE SALINE SOLUTION (P850045/S002)Blairex Laboratories, Inc.1987-08-27
MICRORUPTOR MR-2 ND:YAG LASER SYSTEM (P840012/S003)Meridian AG1987-08-27
NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI (P840024/S009)Cochlear Americas1987-08-27
ULTRAZYME PROTEIN CLEANER (P860061/S001)Advanced Medical Optics, Inc.1987-08-27
HEALON (P810031/S010)Johnson & Johnson Surgical Vision, Inc.1987-08-27
TESLACON(TM) NMR IMAGING SYSTEM (P830051/S014)Technicare Corp.1987-08-26
MAGNETOM (P830081/S014)Siemens Corp.1987-08-26
PLASMA SEPARATION SYSTEM (P820032/S005)Fenwal, Inc.1987-08-25
COSMOS(TM) SYSTEM (P830026/S031)Boston Scientific1987-08-21
HYSKON (32% DEXTRAN 70) (N17511/S008)Coopervision Surgical1987-08-17
CRYSTALENS SALINE SPRAY (P850065/S008)Stericon, Inc.1987-08-17
LC-65 DAILY CONTACT LENS CLEANER (P790024/S012)Advanced Medical Optics, Inc.1987-08-14
GAS PERMEABLE REGIMEN (P820053/S009)Advanced Medical Optics, Inc.1987-08-14
SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH (P820040/S015)Ciba Vision Care1987-08-14
ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS (P840001/S011)Medtronic Neuromodulation1987-08-14
HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE (P850010/S005)Integra LifeSciences Corporation1987-08-13
J-COLL(TM) COLLAGEN ABSORBABLE HEMOSTAT (P830079/S003)ETHICON, Inc.1987-08-12
OCUSIL(TM) CONTACT LENS (P840050/S015)O.S.I. Corp.1987-08-12
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S033)Advanced Cardiovascular Systems, Inc.1987-08-12
GAS PERMEABLE REGIMEN (P820053/S008)Advanced Medical Optics, Inc.1987-08-12
X-70 SOFT CONTACT LENS (P830047/S002)Advanced Medical Optics, Inc.1987-08-12
GYROSCAN(TM) (P840063/S005)Philips Medical Systems, Inc.1987-08-11
DURASOFT CONTACT LENS (N17852/S024)Wesley Jessen Corp.1987-08-10
AMIKACIN ELUTION DISK FOR AUTOBAC (N50485/S015)Organon Teknika Corp.1987-08-10
KONTUR SOFT (METHAFILCON A) LENS (P850078/S008)Kontur Kontact Lens Co., Inc.1987-08-10
AMIKACIN ELUTION DISK FOR AUTOBAC (N50485/S016)Organon Teknika Corp.1987-08-10
BOSTON LENS(R) LENS - CLEAR (P820065/S044)Polymer Technology Corp.1987-08-10
SAUFLON(R) PW (LIDOFILCON B) (P790020/S036)Advanced Medical Optics, Inc.1987-08-10
COSMOS(TM) SYSTEM (P830026/S028)Boston Scientific1987-08-10
DURASOFT(R) 3 FOR EXT WEAR (P830037/S018)Alcon Laboratories, Inc.1987-08-10
TANDEM(R)-E AFP (P840035/S006)Beckman Coulter, Inc.1987-08-05
B&L THERMA-ZYME, FIZZICLEAN (P850093/S004)Bausch & Lomb, Inc.1987-08-05
ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS (P840001/S010)Medtronic Neuromodulation1987-08-05
SURGICEL (N12159/S007)ETHICON, Inc.1987-08-05
BOSTON LENS(R) LENS - CLEAR (P820065/S045)Polymer Technology Corp.1987-08-05
HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE (P850010/S007)Integra LifeSciences Corporation1987-08-03
SOFT CONTACT LENS (N17987/S015)Ciba Vision Corporation1987-07-31
GORE-TEX(R) EXPANDED PTFE SUTURE (P820083/S005)W. L. Gore & Associates, Inc.1987-07-31
NON-PRESERVED SALINE SOLUTION (P850025/S002)Paco Pharmaceutical Services, Inc.1987-07-31
BOSTON LENS(R) LENS - CLEAR (P820065/S042)Polymer Technology Corp.1987-07-31
COOPERVISION PEROXIDE SYSTEM (P830023/S004)Alcon Laboratories1987-07-31
THE SOFT LENS THERMAL DISINFECTING UNIT (P820082/S002)Abbott Medical Optics, Inc.1987-07-31
N.C.G.T. GRAFT (P800058/S005)St. Jude Medical, Inc.1987-07-30
SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH (P820040/S009)Ciba Vision Care1987-07-30
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S032)Medtronic Cardiac Rhythm Disease Management1987-07-28
LC-65 DAILY CONTACT LENS CLEANER (P790024/S014)Advanced Medical Optics, Inc.1987-07-28
CLERZ LUBRICATING & REWETTING EYE DROPS (P800034/S009)Alcon Laboratories1987-07-28
CA 125 ANTIBODY RIA (P850009/S001)Centocor, Inc.1987-07-28
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S010)Medtronic, Inc.1987-07-28
NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S003)Datascope Corp.1987-07-28
B&L THERMA-ZYME, FIZZICLEAN (P850093/S001)Bausch & Lomb, Inc.1987-07-24
PLIAGEL CLEANING SOLUTION FOR HYDROPHILIC(SOFT) CO (P800026/S004)Alcon Laboratories1987-07-23
SOFTHERM SOL. (N18078/S032)Advanced Medical Optics, Inc.1987-07-23
OPTACRYL 60 - CLEAR (P820056/S029)Paragon Vision Sciences1987-07-23
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S001)Beckman Coulter, Inc.1987-07-23
MIRAFLOW EXTRA STRENGTH CLEANER (P850055/S001)Ciba Vision Corporation1987-07-23
NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S019)Coherent Medical Division1987-07-21
AME BONE GROWTH STIMULATOR (P850007/S003)Orthofix, Inc.1987-07-20
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S028)Biomerieux Vitek, Inc.1987-07-20
N.C.G.T. GRAFT (P800058/S001)St. Jude Medical, Inc.1987-07-20
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S027)Biomerieux Vitek, Inc.1987-07-16
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S014)Abbott Laboratories1987-07-16
MODELS PC10 & PC21 (P820049/S021)Advanced Medical Optics, Inc.1987-07-16
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S013)Abbott Laboratories1987-07-16
AMS CEFOTETAN CARD (N50510/S026)Biomerieux Vitek, Inc.1987-07-16
VISTAMARC TORIC (ETAFILCON A) (N18033/S016)Vistakon, Johnson & Johnson Vision Products, Inc.1987-07-14
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S002)Trimedyne, Inc.1987-07-14
GYROSCAN(TM) (P840063/S004)Philips Medical Systems, Inc.1987-07-13
DIASONICS NMR IMAGING SYSTEM (P830053/S026)Diasonics, Inc.1987-07-13
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S002)Beckman Coulter, Inc.1987-07-10
DURASOFT CONTACT LENS (N17852/S018)Wesley Jessen Corp.1987-07-07
STERIDYNE DYNASPRAY (P860050/S002)Optopics Laboratories Corp.1987-07-07
DURASOFT(R) 3 FOR EXT WEAR (P830037/S015)Alcon Laboratories, Inc.1987-07-07
SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (P860040/S001)Wavetouch Technologies, LLC1987-07-07
OCUSIL(TM) CONTACT LENS (P840050/S002)O.S.I. Corp.1987-07-02
UNISOL (P790011/S013)Wesley Jessen Corp.1987-07-02
SOFTHERM SOL. (N18078/S031)Advanced Medical Optics, Inc.1987-07-01
OSTEO CERAMIC HIP (P810048/S011)Smith & Nephew, Inc.1987-07-01
DURASOFT CONTACT LENS (N17852/S019)Wesley Jessen Corp.1987-07-01
MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING (P830061/S003)Medtronic Cardiac Rhythm Disease Management1987-06-30
GORE-TEX{TM} CRUCIATE LIGAMENT PROSTHESIS (P850074/S003)W. L. Gore & Associates, Inc.1987-06-30
SUPRAMID EXTRA SUTURES (N80838/S011)S. Jackson, Inc.1987-06-29
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S029)Advanced Cardiovascular Systems, Inc.1987-06-26
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S031)Advanced Cardiovascular Systems, Inc.1987-06-26
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S031)Medtronic Cardiac Rhythm Disease Management1987-06-26
EBI BONE HEALING SYSTEM MODEL 1020 (P790002/S008)Ahp Eos Buyer, Inc.1987-06-26
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S007)Medtronic, Inc.1987-06-26
MODELS 925, 2040, 2041, 6564 (P840068/S003)Boston Scientific1987-06-26
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S008)Medtronic, Inc.1987-06-26
COSMOS(TM) SYSTEM (P830026/S029)Boston Scientific1987-06-26
COSMOS(TM) SYSTEM (P830026/S026)Boston Scientific1987-06-26
COSMOS(TM) SYSTEM (P830026/S024)Boston Scientific1987-06-26
DURASOFT CONTACT LENS (N17852/S017)Wesley Jessen Corp.1987-06-26
COSMOS(TM) SYSTEM (P830026/S025)Boston Scientific1987-06-26
EBI BONE HEALING SYSTEM(R) (P790002/S009)Ahp Eos Buyer, Inc.1987-06-23
OSTEOSTIM(TM) IMPLANTABLE BONE GROWTH STIMULATOR (P790005/S030)Ahp Eos Buyer, Inc.1987-06-23
COLLASTAT (P810006/S008)Integra LifeSciences Corporation1987-06-23
DURASOFT(R) 3 FOR EXT WEAR (P830037/S014)Alcon Laboratories, Inc.1987-06-22
DIASONICS NMR IMAGING SYSTEM (P830053/S027)Diasonics, Inc.1987-06-22
MICRORUPTOR MR-2 ND:YAG LASER SYSTEM (P840012/S002)Meridian AG1987-06-22
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Track 1987 automatically

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