Atlas FDA

1985

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

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RecordFirmDate
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP (K854009)Roche Diagnostic Systems, Inc.1985-10-15
PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS (K853866)Pantex, Div. Bio-Analysis, Inc.1985-10-15
AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 & (K853888)American Research Products Co.1985-10-15
FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB (K853803)Z.L. Bocknek Laboratories, Inc.1985-10-15
COBURN I/A SYSTEM (K853457)Coburn Optical Ind., Inc.1985-10-15
SUPER MICRO BLADES (K853847)Kdans Surgical, Inc.1985-10-15
PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO (K853865)Pantex, Div. Bio-Analysis, Inc.1985-10-15
WILLIAM HARVEY HYBID OXYGENATOR H-1700 (K853080)C.R. Bard, Inc.1985-10-11
SHILEY CSD EXTENSION LINE WITH FILTER (K852984)Shiley, Inc.1985-10-11
MEDTRONIC MODEL 6405 (K853818)Medtronic Vascular1985-10-11
MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD (K853410)Intermedics, Inc.1985-10-11
FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON (K853213)Fukuda Denshi USA, Inc.1985-10-11
PACEPAC (K852958)Medical Data Electronics1985-10-11
MODEL 43130A DEFIBRILLATOR (K853439)Hewlett-Packard Co.1985-10-11
IPG-300 (K852238)Thornton Associates, Inc.1985-10-11
MEDIC 4 (K853354)Kone Instruments, Inc.1985-10-11
ANGIOMEDICS SOFTIP CATHETER (K852872)Angiomedics, Inc.1985-10-11
BIO PACK MODEL 200 (K853126)Bio Medicus, Inc.1985-10-11
CARDIO DATA PACERECORDER PR3 (K853262)Cardio Data1985-10-11
LIFEPAK 200 (K853564)Physio-Control Corp.1985-10-11
QUADRA CATH ELECT(3MM SIZES) 1990J, JF, JP + JPF (K852920)Neuromed, Inc.1985-10-10
GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 (K853291)Bio-Detek, Inc.1985-10-10
MST-1050-II X-RAY UNIT (K853210)Radiological Engineering, Inc.1985-10-10
WORLD PORTABLE CAUTERY (K852942)Sturgeon Engineering Co.1985-10-10
SPLASH ADAPTOR (K853665)Ohio Medical Research, Inc.1985-10-10
SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030 (K853622)Kleen Test Products1985-10-10
COULTER COUNTER MODEL M5 (K853429)Coulter Electronics, Inc.1985-10-10
PC INTERFACE (K852771)Siemens Elema AB1985-10-10
REI-90/15 (K853175)Radiological Engineering, Inc.1985-10-10
CITREX H (K853897)Bio/Data Corp.1985-10-10
LX 300 TISSUE PROCESSOR (K853938)Innovative Medical Systems, Inc.1985-10-10
OPTICAL DISC UNIT (K852865)General Electric Co.1985-10-10
DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST (K851635)Diagnon Corp.1985-10-10
PARA CHECK (AKA EIGHT CHECK-C) (K852992)Streck Laboratories, Inc.1985-10-10
PRESSURE GAUGE (K853040)Erie Medical1985-10-10
GAS EVACUATION ACCESSORY (K852772)Siemens Elema AB1985-10-10
FINGER TOURNIQUETTE (K853472)Joseph B. Marogil1985-10-10
FDP ASSAY-20 TEST KIT (K852848)American Bioproducts Co.1985-10-10
ESCHMANN ELECTROSURGICAL UNIT, MODEL TD411 (K852935)Eschmann Bros. & Walsh , Ltd.1985-10-10
ELECTROCARDIOGRAPH (K852181)Armstrong Ind., Inc.1985-10-09
SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER (K852281)Armstrong Ind., Inc.1985-10-09
SCHILLER MINISCOPE MS-2 EKG SCOPE (K852282)Armstrong Ind., Inc.1985-10-09
MENISCAL REPAIR SYSTEM (K853829)Concept, Inc.1985-10-08
SUTURE REMOVAL KIT (K853910)Scientific & Medical Care Co.1985-10-08
GAUZE SPONGE (K853742)South Mountain Medical1985-10-08
CHIBA, MADAYAG, POTTS-COURNAND, SELDINGER BIOPSY N (K853623)Co-Medical, Inc.1985-10-08
TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR (K853883)Medical Corp. of America1985-10-08
LIFELINE ENDOCARDIAL UNIPOLAR 487-06 TLE LEAD (K853520)Intermedics, Inc.1985-10-08
CANTROL URINE DIPSTICK CONTROL TWO LEVELS (K853603)Canyon Diagnostics, Inc.1985-10-08
MENISCAL STITCHING KIT (K853801)Aspen Laboratories, Inc.1985-10-08
TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700 (K851405)Trimedyne, Inc.1985-10-07
TENDON LEADER (K853764)Orthopedic Systems, Inc.1985-10-07
ATS 500 TOURNIQUET (K853802)Aspen Laboratories, Inc.1985-10-07
OSTEOGRAF 2040 OSTEOGRAF 4060 (K852199)Osteotech, Inc.1985-10-07
KNEELING ATTACHMENT & CUSHIONED FACE REST SYS FOR (K853797)Cedar Surgical, Inc.1985-10-07
UPPER-CHEST-SUPPORT CUSHION FOR OPERATIONS IN SITT (K853800)Cedar Surgical, Inc.1985-10-07
NEUROSURGICAL HEADREST (K853799)Cedar Surgical, Inc.1985-10-07
PENNINE LINK TUBING (K853839)Samco Industries, Inc.1985-10-07
MODEL 920 ARGON/DYE LASER-FOR DERMATOLOGICAL/USE (K852860)Coherent Medical Group1985-10-07
RAYLOR RETRACTORS (K853796)Cedar Surgical, Inc.1985-10-07
TENDON STRIPPER (K853763)Orthopedic Systems, Inc.1985-10-07
FALCON (POWERED WHEELCHAIR) (K852381)Venturego, Inc.1985-10-07
DRILLING TEMPLATE (K853761)Orthopedic Systems, Inc.1985-10-07
ISOMETRIC ACL DRILL GUIDE (K853762)Orthopedic Systems, Inc.1985-10-07
BONE IMPACTORS (K853798)Cedar Surgical, Inc.1985-10-07
LYTENING 1 (K853832)Amdev, Inc.1985-10-04
BARD-PARKER BILIARY BALLOON CATHETER (K852293)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-10-04
TRAVENOL CAPD Y SET 5C4354 (K853550)Travenol Laboratories, S.A.1985-10-04
QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL (K853933)Quantimetrix Corp.1985-10-04
LASERSAFE EYE SHIELDS (K852404)Lasersafe, Inc.1985-10-04
RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM (K853358)Dentsply Intl.1985-10-04
C-TERMINAL PTH RIA KIT (K853784)Diagnostic Systems Laboratories, Inc.1985-10-04
ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR (K853789)Hemotec, Inc.1985-10-04
KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000 (K853308)Frigitronics of Connecticut, Inc.1985-10-04
PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY (K853867)Pantex, Div. Bio-Analysis, Inc.1985-10-04
INDIRECT OPHTHALMOSCOPE (K853891)Carl Zeiss, Inc.1985-10-04
ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK (K852520)E.I. Dupont DE Nemours & Co., Inc.1985-10-04
INTERNATIONAL MODEL SC CUSTOM IN THE EAR HEARG AID (K853170)Int'L Hearing Aids, Inc.1985-10-04
COLORADO MEDICAL MODEL CTM-3000 (K853735)Colorado Medical, Inc.1985-10-04
LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) (K853906)Biodiagnostic Intl1985-10-04
ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES (K853198)Medical Device Consultants, Inc.1985-10-04
MAID MENTOR ASPIRATION/IRRIGATION DEVRO (K853382)Mentor O & O, Inc.1985-10-04
RIGID ENDOSCOPE (K853514)American Edwards Laboratories1985-10-04
RHODA-LUX LENS BLANKS (K850909)Optatint, Inc.1985-10-04
URODYN 1000 (K853119)Dantec Electronics, Inc.1985-10-04
QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL (K853931)Quantimetrix Corp.1985-10-04
ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH (K853530)E-Z-Em, Inc.1985-10-04
DISPOSABLE, STERILE BIOPSY PUNCH (K853104)August C. Stiefel Research Institute, Inc.1985-10-04
MYREADER 7 (K853284)Scientific Sales Intl., Inc.1985-10-04
VENTREZYME T3 IMMUNOASSAY T3 (K853703)Vxr, Inc.1985-10-04
BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER (K853790)Rocky Mountain Medical Corp.1985-10-04
MYWASHER 5 (K853285)Scientific Sales Intl., Inc.1985-10-04
FEEDING UNITS & TUBES (K853288)I M, Inc.1985-10-04
QCA ENZYMATIC CHOLESTEROL (K853871)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-10-04
PREGNA/TEST (K853269)Modern Diagnostics, Inc.1985-10-03
TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC (K853853)Technicon Instruments Corp.1985-10-03
PHASE II B-12/FOLATE KIT (K853224)Medical & Scientific Designs, Inc.1985-10-03
BETA SCAN TRENDS METER (K851822)Orange Medical Instruments, Inc.1985-10-03
CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO (K851517)Circadian, Inc.1985-10-02
ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM (K853717)Nichols Institute Diagnostics1985-10-02
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Track 1985 automatically

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