Atlas FDA

1991

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

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RecordFirmDate
ANTICARDIOLIPIN ANTIBODY TEST SYSTEM (K903531)Medical Innovations Corp.1991-01-25
FEEL FRESH TOOTHBRUSH KIT (K905090)Fresh Appeal , Ltd.1991-01-25
AIA-PACK HGH (K905757)Tosoh Medics, Inc.1991-01-25
DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555 (K904850)Micro Motors, Inc.1991-01-25
DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK (K904852)Convatec, A Division of E.R. Squibb & Sons1991-01-25
UBI MAGIWEL(TM) ANA QUANTITATIVE (K910033)United Biotech, Inc.1991-01-25
QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM (K904603)Quantitative Medicine, Inc.1991-01-25
ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG (K901320)Ep Medical, Inc.1991-01-25
PREMIER-CRYPTOCOCCAL ANTIGEN (K904393)Meridian Diagnostics, Inc.1991-01-25
MULTIPLE IMAGING XENON ARC AUTO LIGH SOURCE (K905124)Red Wing Imaging, Inc.1991-01-25
COLUMNS LIQUID CHROMATOGRAPHY DPM (K905538)Millpore Corp.1991-01-25
IMMUNOWELL THYROGLOBULIN TEST (K905485)General Biometrics, Inc.1991-01-25
VANCOMYCIN DISK-5 MCG (K905151)Remel Co.1991-01-25
BIPOLAR BIOPSY FORCEPS (K904985)Everest Medical Corp.1991-01-25
PROVOCATIVE SENSITIVITY BALLOON (K901125)Wilson-Cook Medical, Inc.1991-01-25
LAPAROSCOPIC ELECTROSURGICAL DEVICE (K904993)Everest Medical Corp.1991-01-25
ADSON-BECKMAN RETRACTOR, SPINAL (K905445)A. Henniss1991-01-25
SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401 (K905660)Em Diagnostic Systems, Inc.1991-01-25
LUPUS(LE)-LATEX TEST (K905531)Immco Diagnostics, Inc.1991-01-25
PARK CITY SHOULDER POSITIONER (K910031)Orthopedic Systems, Inc.1991-01-24
DENSICOMP 250 (K904587)L. Keroack Co.1991-01-24
LIATEST(R) AT III TEST KIT (K905110)American Bioproducts Co.1991-01-24
E. COLI 0157 LATEX TEST (K903714)Pro-Lab, Inc.1991-01-24
VISTA HPQ SYSTEM (K905259)Philips Medical Systems (Cleveland), Inc.1991-01-24
EUB-565 DIAGNOSTIC ULTRASOUND DEVICE (K896100)Hitachi Medical Corp. of America1991-01-24
ENDOPATH DISPOSABLE SURGICAL TROCAR REDUCER (K904907)ETHICON, Inc.1991-01-24
SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF (K905574)E-Z-Em, Inc.1991-01-24
HYPOALLERGENIC LATEX EXAMINATION GLOVES (K910009)Straitscom1991-01-24
TOPICAL COOLING PAD, MODEL 7000 (K905568)Daily Medical Products, Inc.1991-01-23
SEROZYME CORTISOL TEST KIT (K903975)Serono-Baker Diagnostics, Inc.1991-01-23
FLEXIBLE INTRACARDIAC SUCTION DEVICE (K905008)Gish Biomedical, Inc.1991-01-23
SURE GRIP, HAND CONTROLS MODEL SG-1 (K910072)Howell Ventures , Ltd.1991-01-23
FLAGEN TRIIODOTHYRONINE (T3) ASSAY (K905656)Cyberfluor, Inc.1991-01-23
ST-E1 OVERTUBE (K903842)Olympus Corp.1991-01-23
GEN-PROBE LUMINOMETER-LEADER 450 (K905762)Gen-Probe, Inc.1991-01-23
STORZ S6000 LIGHT SOURCE (K905376)Storz Instrument Co.1991-01-23
CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR (K903104)Datex Division Instrumentarium Corp.1991-01-23
CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II (K904989)Creative Laboratory Products, Inc.1991-01-23
JMB TRADING COMPANY SUNGLASSES (K904161)Jmb Trading Co.1991-01-23
CONDOM SEAL (K903715)Mark Sullivan, M.D., P.C.1991-01-23
620 FLUOROSCOPIC TABLE, TILT OR POWER MEDICAL TAB (K905265)Tri W-G, Inc.1991-01-23
FLUOROSCOPIC TABLE, TILT OR POWER TILTING MED. TAB (K904722)Tri W-G, Inc.1991-01-23
ROMFLEX REHAB EQUIP EXTREMITIES UNIT (K910150)Dyna Flex, Intl.1991-01-23
BML SERIES (K903529)Olympus Corp.1991-01-23
IMX FREE TRIIODOTHYRONINE (K905261)Abbott Laboratories1991-01-23
AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT (K903808)Advanced Med/Surg, Inc.1991-01-22
STORZ DRAEGER ROTOR KERATOME (K904845)Storz Instrument Co.1991-01-22
VIDEO OTOSCOPE (K904802)Jedmed Instrument Co.1991-01-22
GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION (K905463)Angiosystems, Inc.1991-01-22
MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS (K905207)Micro Surgical Instruments Corp.1991-01-22
ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT (K910151)Dyna Flex, Intl.1991-01-18
GENNY DENNY IV SHIELD (K905735)Tadco, Inc.1991-01-18
ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER (K903136)Arzco Medical Electronics, Inc.1991-01-18
ROMFLEX REHAB EQUIP LATERAL FLEXION UNIT (K910149)Dyna Flex, Intl.1991-01-18
ELITE 5000 (K905501)Fischer Imaging Corp.1991-01-18
ATI MEDICAL COMFORT PLUS CPM PAD (K910026)Ati Medical, Inc.1991-01-18
PM GLOVE (K905055)Pm Gloves, Inc.1991-01-18
FREE PROTEIN S REAGENT CAT. NO. 5363 (K904247)Helena Laboratories1991-01-18
OPTEC 2300 AFVT, ARMED FORCES VISION TESTER (K904828)Stereo Optical Co., Inc.1991-01-18
ZENITH COX FLEXION CHIROPRACTIC TABLE (K905685)Williams Manufacturing Co.1991-01-18
ALADERM (K905678)Aladan Corp.1991-01-18
MTS FEMORAL HIP SYSTEM (K903877)3M Company1991-01-18
COMFORT SLEEVED ALL SILICONE FOLEY CATHETER (K905042)Rochester Medical Corp.1991-01-18
SYNAPS (TM) (K903828)Henley Intl.1991-01-18
OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C (K903133)Omron Marshall Products, Inc.1991-01-18
BIFLEX(TM) ANNULOPLASTY RING (K902159)St. Jude Medical, Inc.1991-01-18
SERIES 1500 RESPONDER (K902782)Marquette Electronics, Inc.1991-01-18
PATIENT EXAMINATION GLOVES (K905031)Phoenix Medical Technology, Inc.1991-01-18
COMPACT MONITOR SMK 210,211,230,231,240 (K903917)Ppg Hellige B.V.1991-01-18
MODEL T11 FLUIDOTHERAPY UNIT (K896817)Henley Intl.1991-01-18
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS (K905229)Arrow Intl., Inc.1991-01-18
GASTRO-INTESTINAL ACCU-CULSHURE TM (K903638)Medical Laboratory Automation Systems, Inc.1991-01-18
BUTTON REPLACEMENT GASTROSTOMY DEVICE (K904779)C.R. Bard, Inc.1991-01-18
KODAK SURECELL(TM) STREP A CONTROL FLUID SET (K904589)Eastman Kodak Company1991-01-18
FOCUS T41,T41F,T43, T43F,T44F (K904255)Elamedical1991-01-18
VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER (K904222)Telediagnostic Systems, Inc.1991-01-18
OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE (K903186)Telectronics Pacing Systems, Inc.1991-01-18
ILLUMINA MODEL 780 CO2 LASER SYSTEM (K905637)Heraeus Lasersonics, Inc.1991-01-18
ECLIPSE ICA TRIGLYCERIDES (K905601)Biotope, Inc.1991-01-17
CEDIA PHENYTOIN ASSAY (K905689)Microgenics Corp.1991-01-17
MAGNETIC RESONANCE THERAPY DEVICE (K903675)Mrt, Inc.1991-01-17
DE-TOX TUBES A AND DE-TOX TUBES B (K904326)Dyna-Tek Industries1991-01-17
CREATINE KINASE UV REAGENT SET (K905588)Biochemical Trade, Inc.1991-01-17
ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS (K910086)Roche Diagnostic Systems, Inc.1991-01-17
WILL-CERAM BRUSHES, SUPER BRUSH KIT (K905328)Ivoclar North America, Inc.1991-01-17
SHBG IRMA KIT (K905247)Ventrex Laboratories, Inc.1991-01-17
AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP (K905379)United States Surgical, A Division of Tyco Healthc1991-01-17
THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM (K904816)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-01-17
ECLIPSE ICA DIGOXIN (K905719)Biotope, Inc.1991-01-17
DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176 (K904468)Amresco, Inc.1991-01-17
LAB-SITE SAFETY NEEDLE (K905018)Telos Medical Corp.1991-01-16
STEALTH DILATION CATHETER SYSTEM/MODIFICATION (K904287)Target Therapeutics1991-01-16
SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE (K903823)Smith and Nephew Donjoy, Inc.1991-01-16
ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE (K904801)Orion Life Systems, Inc.1991-01-16
CONDOR DIGITAL INFLATION SYRINGE (K904954)Professional Medical Services1991-01-16
MIDIGOLD 50 (K905322)Ivoclar North America, Inc.1991-01-16
AUTO SUTURE(R) ENDOSCOPIC LDS(TM) LIGATING DEVICE (K905587)United States Surgical, A Division of Tyco Healthc1991-01-16
CYTOASPIRATOR (K902910)H & B Medical Technology, Inc.1991-01-16
DATASCOPE ARTERIAL CANNULA W/ACCESS PORT (K902674)Datascope Corp.1991-01-16
NEUROMED TS8 TEST STIMULATOR (K903814)Neuromed, Inc.1991-01-16
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Every clearance here is in the API, with alerts when new ones post.