Atlas FDA

1981

3,287 FDA 510(k) clearances · Clearance year

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RecordFirmDate
UREOFIX 500 URINE MEASURING SYSTEM (K813082)Burron Medical Products, Inc.1981-12-31
PIPERACILLIN 100 MCG. SENSI DISC (K813441)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-12-31
DADE COLORIMETRIC AMYLASE (K813529)American Dade1981-12-31
WATERS ILEAL RESERVOIR CATHETER (K813494)Waters Instruments, Inc.1981-12-31
SHUNT ADAPTER (K813428)Quinton, Inc.1981-12-31
FLO-GARD 8000 INFUSION PUMP SYSTEM (K813403)Travenol Laboratories, S.A.1981-12-31
GLUCOSE ENZYME-COLOR REAGENT SET (K813412)Diagnostic Specialties1981-12-31
AIR MATTRESS (K813407)Trans World Agency, Inc.1981-12-31
ALT (SGPT) (K813495)Pointe Scientific, Inc.,1981-12-31
SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR (K813447)Rna Medical Corp.1981-12-31
A FLUOROMETER (K813540)American Diagnostic Corp.1981-12-31
MODEL TDS-2450-2 MICROWAVE DIATHERMY SYS (K813006)Technology Applications Group1981-12-31
UREA NITROGEN REAGENT SET (K813415)Anco Medical Reagents & Assoc.1981-12-31
FLAME PHOTOMETER CALIBRATION STANDARDS (K813505)Fisher Scientific Co., LLC1981-12-31
ASTRA TOTAL PROTEIN REAGENT (K813536)Hi Chem, Inc.1981-12-31
DISPOSABLE TRACH SWIVEL CONNECTOR (K813383)Intec.1981-12-31
PEAK FLOW MONITOR (K813414)Biotrine Corp.1981-12-31
PHENYTOIN FLUORESCENT IMMUNOASSAY (K813538)American Diagnostic Corp.1981-12-31
MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL (K813359)American Scientific Products1981-12-31
PHE/TYR KINETIC UV TEST SET (K813449)P-L Biochemicals, Inc.1981-12-31
ELECTRIC SELF STERILIZATION INOCUL. LOOP (K813523)Techhnilab Instruments, Inc.1981-12-31
TRACHEOSTOMY CARE TRAY (K813260)E.M. Adams1981-12-31
ACCUPRO I.V. ADMINISTRATION SET (K813092)American Mcgaw1981-12-31
K60 HABITAT ENVIRONMENT ENCLOSURE (K813208)Kohler1981-12-31
LDH-L (K813496)Pointe Scientific, Inc.,1981-12-31
GENTAMICIN FLUORESCENT IMMUNOASSAY (K813539)American Diagnostic Corp.1981-12-31
SYSTEK #1 EIKEN (K813164)Syn-Kit, Inc.1981-12-31
THERMALOG S STEAM STERILIZATION INTEGRA (K813202)Bio-Medical Sciences, Inc.1981-12-31
AFRICAN GREEN MONKEY BLOOD IN ALSERVERS (K813513)Dutchland Laboratories, Inc.1981-12-31
IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY (K813525)Micromedic Systems1981-12-31
ULTRACHEM GLUC-DH (K813427)Harleco1981-12-31
ALPHATEMP CLINICAL THERMOMETER (K813333)Alpha Omega Engineering Corp.1981-12-31
LIPID PROFILE (K813469)Bio-Analytics Laboratories, Inc.1981-12-31
CERAL-BASE METAL ALLOY (K813243)Sillard Products, Inc.1981-12-31
CUSTOM-IN-THE-EAR HEARING AID (K813316)Telesonic, Inc.1981-12-31
BLOOD GAS ANALYSIS, STANDARDS CONTROLS (K813517)United Diagnostics, Inc.1981-12-31
CHEMFIL (K812858)Dentsply Intl.1981-12-31
CENTIDISC (K813524)Bel-Art Products1981-12-31
NOVAMETRIX NAVAGRAPH MODEL 312 RECORDER (K813351)Novametrix Medical Systems, Inc.1981-12-31
GDC-1136 CASTING ALLOY FOR PORCELAIN-FU (K813200)Ney1981-12-31
EMERGENCY POWER PAC (EMPAC) (K813273)Optical Micro Systems, Inc.1981-12-31
PHADEBAS/PHADEZYM IGE REAGENTS (K813189)Pharmacia, Inc.1981-12-31
AGGLUTEX BARBITURATES TEST KIT (K812988)Hoffmann-La Roche, Inc.1981-12-31
CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET (K813084)Burron Medical Products, Inc.1981-12-31
IN-STOPPER (INJECTION CAP (K813259)Burron Medical Products, Inc.1981-12-31
URIC-ACID (K813511)Medical Analysis Systems, Inc.1981-12-31
AGGLUTEX MORPHINE TEST KIT (K812985)Hoffmann-La Roche, Inc.1981-12-31
DENTAL FLOSS HOLDER (K813248)Sewon Industry1981-12-31
CONNECTORS & ADAPTERS (K813074)Seven Harvest Intl. Import & Export1981-12-31
CATHETER BUBBLE STAND (K813487)Accurate Surgical Instruments Co.1981-12-31
K51,K52 ENVIRONMENT ENCLOSURE (K813207)Kohler1981-12-31
POST-AURICULAR HEARING AID MODEL ASP-103 (K813344)Telesonic, Inc.1981-12-31
PAN SET (K813437)Sterile Design, Inc.1981-12-31
MODEL 6200 OXYGEN CONCENTRATOR (K813320)Hudson Oxygen Therapy Sales Co.1981-12-31
INTRAOSSEOUS DENTAL IMPLANT (K813227)Pacific Implant, Inc.1981-12-31
CELLULOSE ACETATE-CITRATE AGAR HEMOGLO (K813395)Helena Laboratories1981-12-31
SEPCOR TEMPERATURE MONITOR (K813327)Separation Science Corp.1981-12-31
CASTLE #3241 GAS AERATOR (K813201)Sybron Corp.1981-12-31
UNIVERSAL SUCTION PUMP TYPE EUS (K813312)Egnell, Inc.1981-12-31
COMPRESSOR, AIR, PORTABLE (K813311)The Biomed Group1981-12-31
HEMODIALYSATE (K813388)Edlaw Pharmaceuticals, Inc.1981-12-31
OHIO VOLUME INCENTIVE SPIROMETER (K813476)Airco/Ohio Medical Products1981-12-31
UVA HEX UNIT (K813307)Sun Shanty, Inc.1981-12-31
METRONIDAZOLE DIAGNOSTIC DISCS (K813509)Oxoid U.S.A., Inc.1981-12-31
CATHETER REGULAR (K813488)Accurate Surgical Instruments Co.1981-12-31
FREE T4 RIA TEST SET (K813465)Ventrex Laboratories, Inc.1981-12-31
VS600 JET VENTILATOR (K812016)Instrument Development Corp.1981-12-30
125I FERRITIN RADIOIMMUNOASSAY KIT (K812901)Bio-Ria1981-12-30
BBL DIRECTIGEN TEST KIT (K812808)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-12-30
COATEST ANTITHROMBIN (K812829)Kabivitrum, Inc.1981-12-30
VACU-FIL TRANSFER SET (K812928)American Pharmaseal Div. Ahsc1981-12-30
LS 5800 SERIES LIQUID SCINTILLATION (K813472)Beckman Instruments, Inc.1981-12-29
GERARD MEDICAL ELECTRODE TESTER (K813358)Gerard Medical Enterprises, Inc.1981-12-29
TRANSCUTANEOUS ELEC. NERVE STIMULATOR (K813501)Empi1981-12-29
O'CONNOR HOOK PUNCH FORCEP (K813245)Shutt Instruments1981-12-29
LINE POWERED LOW ENERGY DEFIBRILLATOR II (K813471)Narco Scientific1981-12-29
IMAGE ANALYSIS CENTER (K813196)Technicare Corp.1981-12-29
DOUBLE SEAL TUBEGUAZE STERILE BANDAGE (K813308)Scholl, Inc.1981-12-29
MEDIFIX GRADUATED SCALE (K813195)Burron Medical Products, Inc.1981-12-29
EAST WATER UNIT MARK 3 (K812955)Cairco , Ltd.1981-12-29
CEFINASE TM DISCS (K813442)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-12-29
HISTOCAN BIOPSY NEEDLE (K813081)Burron Medical Products, Inc.1981-12-29
TELEMETRY TRANSMITTER & RECEIVER (K813064)Honeywell, Inc.1981-12-29
MRI TOBRAMYCIN RIA KIT (K813516)Microanalytic Research, Inc.1981-12-29
GEL ELECTRODE (K813176)Dyn-A-Med Products1981-12-29
KANTRON 504 HEARTSTATION (K812586)Kantron Cardiovascular, Inc.1981-12-29
BODAI SWIVEL Y (K813324)Sontek Industries, Inc.1981-12-29
MODEL 4200 ELLESTAD STRESS TEST ANALYZER (K813222)Del Mar Avionics1981-12-29
SUCTION CATHETER (K813163)Northern Medical Industries1981-12-29
RHESUS MONKEY BLOOD IN ALSEVER'S (K813512)Dutchland Laboratories, Inc.1981-12-29
NARCO TELECARE ISOFLO PRESSURE MONITOR (K813502)Narco Bio-Systems1981-12-29
NIHON KOHDEN HEART MONITORS OMP 7101-02 (K813444)Nihon Kohden America, Inc.1981-12-29
OMED DISPOSABLE BULLDOG (K813499)Omega-Med Intl., Inc.1981-12-29
PERCUTANEOUS ENTRY NEEDLE, SELDINGER (K813461)Ocean Medical Products, Ltd.1981-12-29
PNEUMO PULSSOR (K813438)Strom Corp.1981-12-29
SBP-16 CLINIC MUSCLE STIMULATOR (K812851)Southwestern Bio-Physical Corp.1981-12-29
SAC-CEL (K813508)Burroughs Wellcome Co.1981-12-29
EDSLAB CATHETER COVER (K813514)American Edwards Laboratories1981-12-29
AFTERLOADING GYNECOLOGICAL APPLICATOR (K813230)Esi1981-12-29
THIGH CUFF: X-LARGE CUFF (K813323)Abco Dealers, Inc.1981-12-29
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Every clearance here is in the API, with alerts when new ones post.