Atlas FDA

1984

260 FDA 510(k) clearances · PMA decision year

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◉ Watch 1984

RecordFirmDate
REPRO-MED - THD (P820034)Repro-Med Systems, Inc.1984-12-26
BONECEMENT (N17755/S031)Zimmer, Inc.1984-12-20
DORNIER LITHOTRIPTER COMPACT TRANSPORTABLE (DLCT) (P840008)Dornier Medtech America, Inc.1984-12-19
SORBI-CARE(TM) DAILY LENS CLEANER (P790024/S004)Advanced Medical Optics, Inc.1984-12-18
OPTI-ZYME(TM) ENZYMATIC CLEANER (P820001/S005)Alcon Laboratories1984-12-18
SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER (N17654/S011)Advanced Medical Optics, Inc.1984-12-17
DEKLENE(TM) (P810028/S005)Deknatel, Inc.1984-12-17
NEODYMIUM-YAG OP LASER OPL-3 (P830064/S002)Coburn Optical Ind., Inc.1984-12-13
DANKER SILICONE LENS (DIMEFOCON-A) (P790010/S004)Ciba Vision Corporation1984-12-13
SOFT MATE(R) LENS DROPS (N18078/S010)Advanced Medical Optics, Inc.1984-12-13
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR (P830070)Ciba Vision Corporation1984-12-11
PERMATINT(R) (P820059/S002)Wesley Jessen Corp.1984-12-10
FLEXLENS (N17976/S003)Paragon Vision Sciences1984-12-10
TCO2M MODEL 818 MONITOR (P810022/S007)Novametrix Medical Systems, Inc.1984-12-04
HEATCASE(TM) (P830001/S001)Wesley Jessen Corp.1984-11-30
ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS (P840001)Medtronic Neuromodulation1984-11-30
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S010)Advanced Cardiovascular Systems, Inc.1984-11-30
AFP MID-PREGNANCY REFERENCE PREPARATION (P820077)Centers for Disease Control and Prevention1984-11-30
PERMATINT(R) (P820059/S006)Wesley Jessen Corp.1984-11-30
ALLERGAN PRESERVED SALINE SOLUTION (N18020/S016)Advanced Medical Optics, Inc.1984-11-29
ALLERGAN PRESERVED SALINE SOLUTION (N18020/S017)Advanced Medical Optics, Inc.1984-11-29
SOFTLENS CLEANING & DISINFECTING SOLN. (N17786/S014)Advanced Medical Optics, Inc.1984-11-29
LENSRINS(R) STERILE PRESERVED SALINE SOLN (P810029/S007)Abbott Medical Optics, Inc.1984-11-29
LC-65 DAILY CONTACT LENS CLEANER (P790024/S007)Advanced Medical Optics, Inc.1984-11-29
LENSRINS(R) STERILE PRESERVED SALINE SOLN (P810029/S006)Abbott Medical Optics, Inc.1984-11-29
LENSOAK (P790023/S009)Abbott Medical Optics, Inc.1984-11-29
ARMSOF SOFT CONTACT LENSE (N18018/S004)Lombart Optical of Virginia, Ltd.1984-11-29
LENS-WET(TM) (P800065/S007)Advanced Medical Optics, Inc.1984-11-29
LENSOAK (P790023/S008)Abbott Medical Optics, Inc.1984-11-29
SOFTLENS CLEANING & DISINFECTING SOLN. (N17786/S013)Advanced Medical Optics, Inc.1984-11-29
LENS-WET(TM) (P800065/S006)Advanced Medical Optics, Inc.1984-11-29
LC-65 DAILY CONTACT LENS CLEANER (P790024/S006)Advanced Medical Optics, Inc.1984-11-29
3M BRAND COCHLEAR IMPLANT SYSTEM/HOUSE DESIGN (P830069)Cochlear Americas1984-11-26
BJORK-SHILEY CARDIAC VALVE (P780008/S015)Shiley, Inc.1984-11-26
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S007)Advanced Cardiovascular Systems, Inc.1984-11-21
OPTECH FRE-FLEX SOFT CONTACT LENS (P810050/S002)Optech, Inc.1984-11-20
POLYCON CONTACT LENS (N18120/S013)Wesley Jessen Corp.1984-11-19
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S008)Telectronics Pacing Systems, Inc.1984-11-19
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S003)St. Jude Medical, Inc.1984-11-19
HEALON (P810031/S006)Johnson & Johnson Surgical Vision, Inc.1984-11-19
COSMOS(TM) SYSTEM (P830026/S003)Boston Scientific1984-11-16
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S005)St. Jude Medical, Inc.1984-11-16
HYDROCURVE PATIENT DISINFECTION UNIT (N17367/S011)Wesley Jessen Corp.1984-11-14
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S011)Advanced Cardiovascular Systems, Inc.1984-11-08
CYBERTACH(TM) 60 PULSE GENERATOR & PROGRAMMER (P820022)Boston Scientific1984-11-07
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S004)Advanced Cardiovascular Systems, Inc.1984-11-07
BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-05
FLEXSOL (N17974/S036)Alcon Laboratories1984-11-02
BOSTON LENS(R) CONDITIONING SOLUTION (P820070/S006)Polymer Technology Corp.1984-11-02
ADAPETTES (N17945/S017)Alcon Laboratories1984-11-02
BOIL N SOAK CONTACT LENS FLUID (N17908/S035)Alcon Laboratories1984-11-02
PREFLEX AND FLEXCARE SOL. (N18143/S024)Alcon Laboratories1984-11-02
SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION (P820031/S001)Bausch & Lomb, Inc.1984-11-01
SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S008)Dow Corning Corp. Healthcare Industries Materials1984-10-31
CUTANIOUS GAS MONITOR (P830008/S001)Sensor Medics Corp.1984-10-29
BSD 1000 HYPERTHERMIA SYSTEM (P820088/S003)Pyrexar Medical, Inc.1984-10-29
ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S001)Nidek, Inc.1984-10-23
TESLACON(TM) NMR IMAGING SYSTEM (P830051/S001)Technicare Corp.1984-10-22
COLLASTAT (P810006/S005)Integra LifeSciences Corporation1984-10-22
COSMAN ICP TELE-SENSOR(R) (P820012/S003)Integra Lifesciences Corp.1984-10-19
DIASONICS NMR IMAGING SYSTEM (P830053/S004)Diasonics, Inc.1984-10-12
CORAB (P780016/S004)Abbott Laboratories1984-10-11
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S001)St. Jude Medical, Inc.1984-10-09
PERMATINT(R) (P820059/S003)Wesley Jessen Corp.1984-10-05
SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH (P820040/S002)Ciba Vision Care1984-10-03
ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062)Nidek, Inc.1984-09-27
BAUSCH & LOMB STERILE PRESERVED SALINE SOLN (P800024/S010)Bausch & Lomb, Inc.1984-09-25
BOSTON LENS(R) CLEANER (P820069/S004)Polymer Technology Corp.1984-09-25
TCO2M MODEL 818 MONITOR (P810022/S006)Novametrix Medical Systems, Inc.1984-09-21
COSMAN ICP TELE-SENSOR(R) (P820012/S005)Integra Lifesciences Corp.1984-09-19
CURESIS PLASMA SEPARATOR (P830010)Organon Teknika Corp.1984-09-19
TCO2M MODEL 818 MONITOR (P810022/S005)Novametrix Medical Systems, Inc.1984-09-13
AUTOBAC MIC TEST SYSTEM (N50524/S019)Organon Teknika Corp.1984-09-13
PDS SUTURE (DYED) (N18331/S012)ETHICON, Inc.1984-09-06
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S010)Medtronic Cardiac Rhythm Disease Management1984-09-05
CMW BONE CEMENT (N18466/S001)Depuy, Inc.1984-08-28
HYDRON HYDROPHILIC CONTACT LENS (P780007/S015)CooperVision, Inc.1984-08-21
CEA-RIA MONOCLONAL (P830066/S001)Abbott Laboratories1984-08-21
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S011)Medtronic Cardiac Rhythm Disease Management1984-08-21
PALACOS R BONE CEMENT (P810020/S001)Smith & Nephew Richards, Inc.1984-08-14
DIASONICS MT/S (MAGNETIC TOMOGRAPHY/SUPERCONDUCTIN (P830053/S001)Diasonics, Inc.1984-08-14
HYDRO MARC LENSES (HYDROPHILIC) (N18033/S006)Vistakon, Johnson & Johnson Vision Products, Inc.1984-08-10
EASY EYES (TM) (P830009/S004)Eaton Medical Corp.1984-08-10
SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) (P800035/S007)Curasan AG1984-08-07
LENSRINS(R) STERILE PRESERVED SALINE SOLN (P810029/S005)Abbott Medical Optics, Inc.1984-08-07
SAUFLON(R) PW (LIDOFILCON B) (P790020/S021)Advanced Medical Optics, Inc.1984-08-02
HYDROCURVE (N17752/S018)Ciba Vision Corporation1984-07-31
ZYDERM COLLAGEN IMPLANT (ZYDERM CI) (P800022/S009)Allergan1984-07-26
BSD 1000 HYPERTHERMIA SYSTEM (P820088/S002)Pyrexar Medical, Inc.1984-07-24
SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER (N17654/S009)Advanced Medical Optics, Inc.1984-07-24
ALCON ENZYME CLEANER (P820001/S003)Alcon Laboratories1984-07-24
AMIKACIN ELUTION DISK FOR AUTOBAC (N50485/S013)Organon Teknika Corp.1984-07-20
AMIKACIN ELUTION DISK FOR AUTOBAC (N50485/S012)Organon Teknika Corp.1984-07-20
BOSTON LENS(R) LENS - CLEAR (P820065/S005)Polymer Technology Corp.1984-07-18
WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS (P810005/S011)Ciba Vision Care1984-07-18
SUPERSTAT (P810040/S003)Superstat Corp.1984-07-18
SAUFLON(R) PW (LIDOFILCON B) (P790020/S019)Advanced Medical Optics, Inc.1984-07-17
WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES (P800011/S006)Ciba Vision Corporation1984-07-16
ACCUGEL 1T (N17734/S003)Strieter Laboratories, Inc.1984-07-13
PLAIN GUT SUTURES (N84380/S004)Deknatel, Inc.1984-07-12
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Track 1984 automatically

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