Atlas FDA

1985

4,483 FDA 510(k) clearances · Clearance year

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RecordFirmDate
AUTOSCAN W/A SYSTEM (K854448)American Micro Scan1985-11-26
MEDSURG ARTHROGRAM TRAY (K854292)Medsurg Industries, Inc.1985-11-26
MEDSURG PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM (K854297)Medsurg Industries, Inc.1985-11-26
ACOUSTICALLY-COUPLED ELECTRONIC PHANTOM 84-410 (K853755)Victoreen, Inc.1985-11-26
MED SURG PERCUTANEOUS ASPIRATION BIOPSY(PAB)TRAY (K854291)Medsurg Industries, Inc.1985-11-26
EXCEL BRACKET ADHESIVE (K854050)Johnson & Johnson Professionals, Inc.1985-11-26
PORT-GARD (K854019)Cormed, Inc., Sub. C.R.Bard, Inc.1985-11-26
CORNING MAGIC MAB HCG RADIOIMMUNOASSAY (K854024)Corning Medical & Scientific1985-11-26
KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 (K851149)Keymed, Inc.1985-11-26
PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS (K853554)Kallestad Laboratories, Inc.1985-11-26
UNITEK LIFT-OFF DEBRACKETING INSTRUMENT (K854088)Unitex Corp.1985-11-26
RAICHEM/K.E (K854540)Reagents Applications, Inc.1985-11-26
SYS*STIM 207 MODEL ME 207 (K853750)Mettler Electronics Corp.1985-11-26
TECHNICON RA-500 SYSTEM (K854345)Technicon Instruments Corp.1985-11-26
ALT(OPTIMIZED) REAGENT (K854502)Sigma Diagnostics, Inc.1985-11-25
POROCOAT SYNATOMIC UNICONDYLAR KNEE (K853020)Depuy, Inc.1985-11-25
IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN (K854180)Clinical Data, Inc.1985-11-25
EGNELL COMPACT SUCTION PUMP (K853917)Egnell, Inc.1985-11-25
IN-VITRO TEST FOR THE DETERMINATION OF CREATININE (K854178)Clinical Data, Inc.1985-11-25
IN-VITRO TEST DETERMINATION OF ALBUMIN (K854181)Clinical Data, Inc.1985-11-25
IN-VITRO TEST DETERMINATION OF URIC ACID (K854185)Clinical Data, Inc.1985-11-25
BIOPSY TRAY I & II (K854095)North Coast Medi-Tek1985-11-25
SHAW SUN SYSTEMS 1000, 2000 & 3200 (K854515)Shaw Sun Systems1985-11-25
PLASTELAST AND/OR ELASTOPLASTE (K854006)Cp Medical1985-11-25
IN-VITRO TEST DETERMINATION OF TRIALYCERIDE (K854182)Clinical Data, Inc.1985-11-25
72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL (K850682)Kent Laboratories, Inc.1985-11-25
IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL (K854179)Clinical Data, Inc.1985-11-25
AST(OPTIMIZED) REAGENT (K854503)Sigma Diagnostics, Inc.1985-11-25
EGNELL UNIVERSAL SUCTION PUMP (K853909)Egnell, Inc.1985-11-25
OMIDERM WOUND & BURN DRESSING (K851885)Biosystems Assoc.1985-11-25
TDX R OPIATES (K854421)Abbott Laboratories1985-11-25
CANTROL SPINAL FLUID CONTROL (K854190)Canyon Diagnostics, Inc.1985-11-25
SPECTRA 724 (K854498)Daavlin Co.1985-11-25
TDX CORTISOL (K854419)Abbott Laboratories1985-11-25
IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO (K854188)Clinical Data, Inc.1985-11-25
IN-VITRO TEST DETERMINATION OF SGOT (AST) (K854187)Clinical Data, Inc.1985-11-25
CHEMSPOR (K844479)American Sterilizer Co.1985-11-25
P.C.A. UNIVERSAL ACETABULAR COMPONENT SYSTEM (K853886)Howmedica Corp.1985-11-25
DIESSE CRP TEST KIT (K854221)Marvic Interpharma, Inc.1985-11-25
ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD (K854366)American Monitor Corp.1985-11-25
TOTAL PROTEIN (K854553)American Monitor Corp.1985-11-25
IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE (K854177)Clinical Data, Inc.1985-11-25
CALCITONIN RIA KIT (K854240)Diagnostic Systems Laboratories, Inc.1985-11-22
UNILOC TOTAL HIP PROSTHESIS (K851409)Serrano Intl.1985-11-22
EXTERNAL MECHANICAL FASTENER (K854068)Wells Johnson Co.1985-11-22
KIRSCHNER BIPOLAR ENDOPROSTHETIC HEAD (K853795)Kirschner Medical Corp.1985-11-22
APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT (K853524)Intermedics Orthopedics1985-11-22
DELTA-LITE CASTING RESIN (K854341)Johnson & Johnson Professionals, Inc.1985-11-22
GLUCOSE REAGENT SET (GOD/TRINDER) (K854335)Sterling Diagnostics, Inc.1985-11-22
MON-A-THERM SUBCUTANEOUS TEMP. SENSOR (K853392)Mon-A-Therm, Inc.1985-11-22
MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL (K854420)Meadox Surgimed, Inc.1985-11-22
SILICONE OIL 350 CNETISTOKE (K854273)Pacific Medical Industries1985-11-22
FALKON STRETCH (K854432)G.B.F. Industries, Inc.1985-11-22
MIDAS REX SURGICAL RUBBER DAM (K854462)Midas Rex Pneumatic Tools, Inc.1985-11-22
THE NEW MCINTYRE CANNULA (K853777)Microsurgical Technology, Inc.1985-11-21
CPAP BLOWER (K853944)American Air & Process, Inc.1985-11-21
PLAYTEX LIGHT'N GENTLE UNSCENTED/DEODORANT/MINI TA (K854258)Intl. Playtex, Inc.1985-11-21
BARD PARKER 150CC BELLOWS RESERVOIR (K854424)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-11-20
THERMO TRIM (K852637)Suntec Health & Fitness Group, Inc.1985-11-20
ALPHA SUPER KART (K853766)Alpha Unlimited, Inc.1985-11-20
IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES (K854423)Dynatech Laboratories, Inc.1985-11-20
MULTISCAN 7 (K853852)Multiscan, Inc.1985-11-19
KIRSCHNER COMPRESSION HIP SCREW SYSTEM (K854205)Kirschner Medical Corp.1985-11-19
WIRE CUTTING PLIERS OR LINEMAN'S PLIERS (K854390)Med-Tool, Inc.1985-11-19
ALLOY B (K853845)North American Alloys, Inc.1985-11-19
LIGHT CURE FILLING MATERIAL (K853055)Foremost Dental Mfg., Inc.1985-11-19
MR 700 MICROPLATE READER 012-700-1000 (K854303)Dynatech Laboratories, Inc.1985-11-19
ROUND SUCTION DRAIN (K854418)Sil-Med Corp.1985-11-19
JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2 (K853470)Toshiba Medical Systems1985-11-19
I.C.L.S. COMPULYZER (K854055)Integrated Computerized Laboratory Systems, Inc.1985-11-19
OMNIGRAPH 4000(ELECTROCARDIOGRAPH) (K852652)Telemed Div.1985-11-19
ES 22 (K854243)Boehringer Mannheim Corp.1985-11-19
ADULT ABSORBENT INCONTINENT BRIEF (K854408)Weyerhaeuser Co.1985-11-19
GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO (K851244)Cook, Inc.1985-11-19
URINARY DRAINAGE BAG (K854480)The West Co., Inc.1985-11-19
CHEMPRO 1000 (K854260)Sen Tech Medical Corp.1985-11-19
SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000 (K851625)Eaton Medical Group1985-11-19
CARDIORATER CR7 (K852910)Cardiac Recorders, Ltd.1985-11-19
CONICAL COLLAR HIP PROSTHESIS (K854046)Kirschner Medical Corp.1985-11-19
AXICARE CM-14 AUTOMATIC BREAST PUMP (K853107)Crystal Medical Products, Inc.1985-11-19
PLEUR-EVAC II AUTOTRANSFUSION SYSTEM (K854301)Deknatel, Inc.1985-11-19
DICOR CASTABLE CERAMIC-ALL PORCELAIN BRIDGES (K853707)Dentsply Intl.1985-11-19
WATER DRIVEN BREAST PUMP BY BABY NURSE (K853326)Baby Nurse1985-11-19
WALLACH ZOOM COLPOSCOPE (K853389)Wallach Surgical Devices, Inc.1985-11-19
SYS STIM 206 MODEL ME206 (K851735)Mettler Electronics Corp.1985-11-19
MULLER SELF LOCKING TOTAL HIP (K853768)Protek, Inc.1985-11-19
KIRSCHNER BONE FIXATION FASTENER SYSTEM (K854445)Kirschner Medical Corp.1985-11-19
CDC ANAEROBE BLOOD AGAR (K854455)R. Kent Richards, Inc.1985-11-18
COLUMBIA CNA AGAR W/5% SHEEP BLOOD (K854457)R. Kent Richards, Inc.1985-11-18
OMRON DIGITAL BP MONITOR HEM-700C (K853260)Omron Tateisi Electronics Co.1985-11-18
TRYPTIC SOY BLOOD AGAR (K854454)R. Kent Richards, Inc.1985-11-18
P.E.Z. AGAR (PHENYLETHANOL AGAR) (K854453)R. Kent Richards, Inc.1985-11-18
MONAGHAN RVM, MODEL 760 OR MODEL 761 (K853047)Monaghan Medical Corp.1985-11-18
ISOVOL-EXCHANGE TRAY (K852167)Rocky Mountain Medical Corp.1985-11-18
HEKTOEN ENTERIC AGAR (K854449)R. Kent Richards, Inc.1985-11-18
PHADEBAS RAST TEST ALLERGEN DISCS (K853969)Pharmacia, Inc.1985-11-18
INSULIN PUMP INSUMAT 229 (K853393)Medix Medical Electronics (U.S.A.), Inc.1985-11-18
SUNBEAM HEALTH MONITOR MODEL NO. 7600 (K852795)Aanson Scale Co.1985-11-18
ACCESS DIGIWIPE SYSTEM (K853141)Medtech Products, Inc.1985-11-18
SYNECTICS LIBERTY SYS COMPRIS DIGITRAPPER MK II MO (K853648)Synectics-Dantec1985-11-18
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Track 1985 automatically

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