Atlas FDA

1991

4,235 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SUMO GLASS IONOMER CEMENT (K913519)Ortho Source1991-11-19
POWER RECLINER WHEELCHAIR (K914091)Everest & Jennings, Inc.1991-11-19
INTERSON ENDOCAVITY PROBE/ALOKA ULTRASOUND SYSTEM (K911114)Interson Corp.1991-11-19
WALKAWAY TM 40 (K911400)Baxter Healthcare Corp1991-11-19
EXMOOR SILICONE RUBBER SHEET (K911503)Exmoor Plastics , Ltd.1991-11-19
FLUROSPOT H VERSION 2 (K914525)Siemens Medical Solutions USA, Inc.1991-11-19
SONGER(TM) CABLE SYSTEM (K913735)Danek Medical, Inc.1991-11-18
SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE (K911837)Acufex Microsurgical, Inc.1991-11-15
MERIT CUSTOM KIT (K913682)Merit Medical Systems, Inc.1991-11-15
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3 (K912015)Empi1991-11-15
VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) (K913692)Bentley Laboratories, Inc.1991-11-15
DAVOL POST-OP AUTOTRANSFUSION SYSTEM (K913684)Davol, Inc.1991-11-15
IRIS OCULIGHT(R) SLX (K913430)Iriderm Div.1991-11-15
SAS RUBBER PRODUCTS CO./LATEX EXAMINATION GLOVES (K911939)Overseas Import & Export Dist.1991-11-15
ELECTROCONDUCTIVE MEDIA (K904377)Henley Intl.1991-11-15
VITALMAX 510/520 (K912880)Pace Tech, Inc.1991-11-14
DUOMAT 3 AMALGAMATOR (K914340)Degussa AG1991-11-13
SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS (K914529)Oasis Medical, Inc.1991-11-13
MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011 (K914696)Medix Biotech, Inc.1991-11-13
Q-TENS (K912460)Quantitative Medicine, Inc.1991-11-13
NELLCOR(R) N-180 PULSE OXIMETER (K913695)Nellcor, Inc.1991-11-13
PLATINUM FOIL PLATINUM MILING WAFER (K914627)Metalor Dental USA Corp.1991-11-13
EMS SINGLE USE MANUAL RESUSCITATORS (K912203)Engineered Medical Systems1991-11-13
MODULAR CALCAR REPLACEMENT (K913649)Zimmer, Inc.1991-11-13
ULTRACROWN(TM) PD ALLOY POST-SOLDER (K913860)Dentsply Intl.1991-11-13
MEDICAL DESIGNS REUSABLE CARBON RUBBER ELECTRODE (K914384)Medical Design & Manufacturing Corp.1991-11-13
MDT/CASTLE 2000 SURGICAL LIGHTS (K914076)Mdt Corp., Inc.1991-11-13
ARGEBOND 80 (K913704)Argen Precious Metals, Inc.1991-11-13
BATEMAN UPF-III BIPOLAR ENDOPROSTHESIS SYSTEM (K913632)Kirschner Medical Corp.1991-11-13
MDT/CASTLE PURUS DENTAL UNIT (K914697)Mdt Corp., Inc.1991-11-13
JOHNSON AND JOHNSON POWER SYSTEM (K913629)Johnson & Johnson Orthopaedics, Inc.1991-11-13
VERRES NEEDLES 5 & 6 INCHES (K911179)Northgate Technologies, Inc.1991-11-13
KERALLOY NON-GAMMA 2 AMALGAM (K912992)Wilde-USA, Inc.1991-11-13
CLA-1400 SYSTEM (K914851)Gaymar Industries, Inc.1991-11-13
CONVERSIL FL AND CONVERSIL P (K913583)Wilde-USA, Inc.1991-11-13
RICH-MAR MODEL II ULTRASOUND (K913981)Rich-Mar Corp.1991-11-13
MODEL C386 ISOLETTE(R) INFANT INCUBATOR (K913291)Air-Shields, Inc.1991-11-13
UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY (K912247)Laser Engineering, Inc.1991-11-13
STOMAVISION (STV) (K913464)Trophy Radiologie1991-11-13
MIXOMAT AMALGAMATOR (K914341)Degussa AG1991-11-13
BACK MASTER (K914394)Progressive Electrical Therapeutics1991-11-13
LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET (K914117)Ocular Instruments, Inc.1991-11-13
MICRO-Q (K912463)Quantitative Medicine, Inc.1991-11-13
PART 872 DEGUFILL H & DEGUFILL M DA (K914368)Degussa AG1991-11-13
RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED (K914195)Rondex Products, Inc.1991-11-08
HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED (K913312)Target Therapeutics1991-11-08
ORIGINEEDLE, MODIFICATION (K913816)Origin Medsystems, Inc.1991-11-08
RONDEX MASKS MODELS 9015/9011/901102 MODIFIED (K914196)Rondex Products, Inc.1991-11-08
HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED (K911779)Target Therapeutics1991-11-08
DANBY D.S.P. SYRINGE PUMP (K911103)Isys Medical , Ltd.1991-11-08
THE BIG EASY Y-ADAPTER (K914046)Microvena Corp.1991-11-08
TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL (K913371)Creative Laboratory Products, Inc.1991-11-08
MODEL DLASE 500 ND:YAG LASE SYS:INTRA SFT TIS SURG (K914677)Sunrise Technologies, Inc.1991-11-08
SAPPHIRE 4ME EMG/EP SYSTEM (K912775)Medelec Intl. Corp.1991-11-08
TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM (K911734)Northland Cataract & Eye Care Clinic1991-11-07
STETHOSCOPE (K914100)Atlas Medical Products, Inc.1991-11-07
3M ANTI-DSDNA FAST TEST (K913653)3M Diagnostic Systems, Inc.1991-11-07
IL TEST(TM) PHENCYCLIDINE (K913743)Instrumentation Laboratory CO1991-11-07
MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS) (K913533)Hewlett-Packard Co.1991-11-07
SAFETY PLUS DENTAL INJECTION NEEDLE (K913573)Specialites Septodont1991-11-07
SNOWDEN-PENCER INSUFFLATOR TUBING SET (K913835)Snowden-Pencer1991-11-07
ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST (K913357)Lifescan, Inc.1991-11-07
PATIENT EXAMINATION GLOVES (K913776)P.T. Irama Dinamika Latex1991-11-07
TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY (K912404)Hewlett-Packard Co.1991-11-07
THERMA-H (K905276)Kure Swiss Medical AG Corp.1991-11-07
DENTOMAT 3 AMALGAMATORS (K914339)Degussa AG1991-11-07
TRIGLYCERIDES REAGENT SET (K914609)Sterling Diagnostics, Inc.1991-11-07
POLARIS, OPHTHALMOLOGY (K911926)Pfizer Laser Systems1991-11-07
RELIABLE CONE STYLE FACE MASK (K913558)Anago, Inc.1991-11-07
VARIAN C-SERIES CLINACS (CLINAC 2300C/D) (K913119)Varian Assoc., Inc.1991-11-07
CARDIODYNE KINETORR/PC BLOOD PRESSURE MONITORS (K911871)Cardiodyne, Inc.1991-11-07
MODEL DLASER 1000 ND;YAG LASER SYSTEM (K914568)Sunrise Technologies, Inc.1991-11-07
ELECTROSURGICAL CUTTING/COAGULATION DEVICE/ACCESS (K914066)Laparomed Corp.1991-11-07
DELPHIN II CENTRIFUGAL SYSTEM (K913176)3M Health Care, Sarns1991-11-07
HUMAN BETA-2 MICROGLOBIN EN-RID KIT (K913131)The Binding Site, Ltd.1991-11-07
ROCKET SURGICAL SKIN MARKING PEN (K912730)West Texas Lighthouse For the Blind1991-11-07
IL TEST(TM) AMPHETAMINE (K913738)Instrumentation Laboratory CO1991-11-07
VASCUMAP MEDICAL AIR PLETHYSMOGRAPH (K914200)Carolina Medical Electronics1991-11-07
INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 (K905608)Stellar Bio Systems, Inc.1991-11-07
LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP (K913616)Implant Technology, Inc.1991-11-07
PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF (K914628)Medical Resources, Ltd.1991-11-07
IL TEST(TM) OPIATE (K913742)Instrumentation Laboratory CO1991-11-07
OPUS(R) LH TEST SYSTEM (K913938)Pb Diagnostic Systems, Inc.1991-11-07
ACCU-BEAM LAPAROSCOPIC SYSTEM (K910978)Tti Medical1991-11-07
UNICATH EP. (K913685)Xre Corp.1991-11-07
BAXA PCA INFUSOR (K910257)Baxa Corp., Sub. of Cook Group, Inc.1991-11-07
SPIKED WASHER (K914472)Synthes (Usa)1991-11-07
OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR (K913559)Osteo AG1991-11-07
AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITOR (K913523)Omron Healthcare, Inc.1991-11-06
DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON (K910997)Datascope Corp.1991-11-05
Q4500 STREE TEST MONITOR (K910017)Quinton, Inc.1991-11-05
ANTI-DSDNA ANTIBODY TEST (K913041)Helix Diagnostics, Inc.1991-11-05
P54 BTE HEARING AID (K914800)Philips Hearing Instruments Co.1991-11-05
GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE (K914447)W. L. Gore & Associates, Inc.1991-11-05
ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION (K912477)Interventional Therapeutics Corp.1991-11-05
X-RAY TABLE (K914165)Siemens Medical Solutions USA, Inc.1991-11-05
HEARING AID, UNITRON MODEL VISTA 4000 (K914689)Unitron Industries, Inc.1991-11-05
COORDINATOR, CABLE INPUT (K914725)Cardiotronics, Inc.1991-11-05
0.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPE (K913074)Terumo Medical Corp.1991-11-05
VARIAN CLINAC 600SR (K913174)Varian Assoc., Inc.1991-11-05
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Track 1991 automatically

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