Atlas FDA

1983

3,564 FDA 510(k) clearances · Clearance year

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RecordFirmDate
PORTABLE AUTOCLAVES (K830931)Arnold & Sons1983-07-27
UNIVERSAL LEVEL SENSOR (K831879)3M Health Care, Sarns1983-07-26
HERPELISA KIT (K822883)M.A. Bioproducts1983-07-26
MINI PULSATOR (K831474)Medelco , Ltd.1983-07-26
GAUZE CONVERSION CLASS II STERILE (K832213)Winn Hirsch & Assoc.1983-07-26
SURGICAL FACE MASK-DISPOSABLE (K832194)Tecnol New Jersey Wound Care, Inc.1983-07-26
TEMP. BIPOLAR EPICARDIAL LEAD (K831645)Cordic Corp.1983-07-26
CIRCUT 1 (K832147)Brimfield Scientific Instruments1983-07-26
SOLARCRYL CUSTOM TRAY MATERIAL (K831293)Solar Dental Co., Inc.1983-07-26
ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG (K831271)Ortho Diagnostic Systems, Inc.1983-07-26
BURLINGTON STOCKINETTE (K822770)Balfour, Inc.1983-07-26
FR ROOT CANAL SEALER (K830764)Shizai Corp.1983-07-26
MAPROTILINE (K831735)Utak Laboratories, Inc.1983-07-26
EGG YOLK AGAR (K831827)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-07-26
COAXIAL BALLOON URETHRAL DILATOR (K831384)Thomas J. Fogarty, M.D.1983-07-26
GAUZE CONVERSION CLASS I-NON-STERILE (K832214)Winn Hirsch & Assoc.1983-07-26
DELTA CONDUCTIVE ADHESIVE ELECTROSURG- (K832157)Delta Medical Electronics, Inc.1983-07-26
ULTRA PULSATOR MF (K831473)Medelco , Ltd.1983-07-26
MEDTRONIC MODELS 4012 & 4512 (K832099)Medtronic Vascular1983-07-26
AMOXAPINE 8-HYDRO-XYAMOXAPINE (K831734)Utak Laboratories, Inc.1983-07-26
I.V. BAG ADDISEAL (K832247)Baxa Corp., Sub. of Cook Group, Inc.1983-07-26
IMPLANTABLE CARDIAC PACING LEADS (K831767)Oscor, Inc.1983-07-26
ULTRA PULSATOR (K831472)Medelco , Ltd.1983-07-26
CARDIO ARRHYTHMIA TRANSMITTER C.A.T (K830903)Cardio Technology , Ltd.1983-07-26
MICROELISA COMP (K831658)Organon Teknika Corp.1983-07-26
LASER BRONCHOSCOPE (K831240)Eder Instrument Co, Inc.1983-07-26
POLYCHACO FIA-ABS TEST FOR SYPHILIS (K831296)Parasitic Disease Consultants1983-07-26
AVL 0073 MICROSAMPLER (K831395)Avl Scientific Corp.1983-07-26
PM-3 (K831750)Delta Medical Industries1983-07-26
CAFFINE TOXICOLOGY CONTROL (K831738)Utak Laboratories, Inc.1983-07-26
HEATING BLOCK MICROELISA SYSTEM (K831642)Organon Teknika Corp.1983-07-26
STRIPREADER MICROELISA SYSTEM (K831643)Organon Teknika Corp.1983-07-26
HEARING AID G3H & G3T (K832129)Widex Hearing Aid Co., Inc.1983-07-26
WHISTLER IN-LINE PRESSURE RELEASE VALVE (K831246)Airlife, Inc.1983-07-26
BAXA ADDISEAL (K832254)Baxa Corp., Sub. of Cook Group, Inc.1983-07-26
FLURAZEPAM TOXICOLOGY CONTROL (K831741)Utak Laboratories, Inc.1983-07-26
TRIGLYCERIDES REAGENT SET (K831858)Stanbio Laboratory1983-07-22
CHOLESTEROL-ENZYMATIC REAGENT SET (K831863)Stanbio Laboratory1983-07-22
URIC-ACID TEST ENZYMATIC COLORIMETRIC (K831864)Stanbio Laboratory1983-07-22
RADIAL IMMUNO-TEST FOR HUMAN FACTOR B (K831959)Kent Laboratories, Inc.1983-07-19
THE BLOOM STETHOSCOPE (K830796)Stethophonics, Inc.1983-07-19
TALL FLOOR STAND TFS-01 (K831939)Sorensen Research1983-07-19
USE 77 ULTRASONIC NEBULIZER (K832086)Medlog GmbH Marketing Services1983-07-19
TRANSCUTANEOUS OXYGEN MONITOR OPTION (K831744)Ge Medical Systems Information Technologies1983-07-19
RABBIT ANTISERUM TO HUMAN C4 (K831906)Dako Corp.1983-07-19
DRIONIC (K831320)General Medical Co.1983-07-19
DISPOSABLE SCALPELS (K831798)I M, Inc.1983-07-19
EXTERNAL INCONTINENCE CATHETER TRAVEL (K832106)Plasco, Inc.1983-07-19
NEURO-PULSER 2 TRANSCUTAN. ELEC. NERVE (K831850)Th Charters, Inc.1983-07-19
RENAK (K831694)Hoffmann-La Roche, Inc.1983-07-19
RADIAL IMMUNO-TEST FOR HUMAN C-REACTI (K831958)Kent Laboratories, Inc.1983-07-19
FLUORESCEIN CONJUGATED IMMUNOGLOBULIN (K831903)Dako Corp.1983-07-19
INFUSION PUMP (K831953)Cryosan, Inc.1983-07-19
PECGASYS REMOTE TRANSMISSION UNIT (K831092)Datamedix1983-07-19
TRICYCLIC ANTIDEPRESSNATS VI (K831737)Utak Laboratories, Inc.1983-07-19
EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO (K831979)Syva Co.1983-07-19
HEMOSTATS (K831797)I M, Inc.1983-07-19
COLOSTOMY BAG (K830841)C & D Colostomy Pad Corp.1983-07-19
NEONATAL NASOGASTRIC FEEDING TUBE- (K831328)Corpak Medsystems1983-07-19
BETA SCAN NORMAL CONTROL SOLUTION (K831523)Orange Medical Instruments, Inc.1983-07-19
KNEE PROSTHESIS-TIBIAL COMPONENT (K830927)Johnson & Johnson Professionals, Inc.1983-07-19
MULTICHEM ENZYMATIC CHOLESTEROL SYS (K831700)Simmler, Inc.1983-07-19
RABBIT ANTISERUM TO HUMAN IGM (K831907)Dako Corp.1983-07-19
MICRO-THIN SURGICAL GLOVE (K831565)Ansell, Inc.1983-07-19
VAPOR-PHASE HUMIDIFIER SYSTEM (K831556)Cygnus Research Corp.1983-07-19
PLASTIC TUBING CONNECTORS (K831920)Polymer Technology Corp.1983-07-19
GLUCOSE REAGENT B6360-11 (K831634)American Scientific Products1983-07-19
COMPRESSAR DISPOSABLE DISC (K831337)Instromedix, Inc.1983-07-19
RABBIT ANTISERUM TO HUMAN KAPPA LIGHT (K831904)Dako Corp.1983-07-19
HCG ACCU-STICK (K831604)Btc Diagnostics, Inc.1983-07-19
DISPOSABLE HEMOSTAT (STRAIGHT&CURVED (K831662)Medcare Products1983-07-19
ASTRA SYSTEMS ENZYME MODULE LD-P (K832048)Beckman Instruments, Inc.1983-07-19
TEST FOR HUMAN ALPHA ONE ACID GLYCO- (K831960)Kent Laboratories, Inc.1983-07-19
SCOLIMETER (K831898)Dr. Micheal A. Sabia1983-07-19
LEG BAG EXTENTION TUBE-STERILE (K832107)Plasco, Inc.1983-07-19
EMIT SERUM TRICYCLIC ANTIDEPRESS CALIBRA (K831980)Syva Co.1983-07-19
FREEDOM 19 RECREATIONAL WHEELCHAIR (K831510)Carbonite Corp.1983-07-19
VASCULAR GRAFT PROSTHESIS EXPANDED MICR (K830543)Impra, Inc.1983-07-19
MONOBLOCK PROSTOPERATIVE TENS ELECTRODE (K832145)New Dimensions IN Medicine, Inc.1983-07-19
GP-303 (K831583)Hirata Sangyo Co. USA, Inc.1983-07-19
FLOW-CALIBRATION MODULE (K831758)The Perkin-Elmer Corp.1983-07-19
THEOPHYLLINE ACA CALIBRATOR (K831933)E.I. Dupont DE Nemours & Co., Inc.1983-07-19
CURAY-ECLIPSE VISIBLE LIGHT CURED ORTHO (K831495)Scientific Pharmaceuticals, Inc.1983-07-18
QUANTIMUNE HFSH RIA HUMAN FOLLICLE- (K831742)Bio-Rad1983-07-18
GILCHEM TOTAL BILIRUBIN REAGENT (K831843)Gilford Diagnostics1983-07-18
ANTI-ENA TEST (K831292)Meloy Laboratories, Inc.1983-07-18
CALIBRATOR 282 (K831872)Bionostics, Inc.1983-07-18
STOMACH TUBE LEVIN TUBE (K831974)Medline Industries, Inc.1983-07-18
SPINAL FLUID TOTAL PROTEIN CONTROL (K831527)Quantimetrix Corp.1983-07-18
MONOJET SPS BLOOD COLLECTION TUBE (K831719)Sherwood Medical Co.1983-07-18
CATHETER INSERTION TRAYS, VARIOUS #'S (K831807)American Pharmaseal Div. Ahsc1983-07-18
APNEA/BRADYCARDIA MONITOR HB 95 (K830666)Harvey-Bostwick, Inc.1983-07-18
PERCUTANEOUS CATHETER INSERTION TRAY (K831729)American Pharmaseal Div. Ahsc1983-07-18
WEDGE PRESSURE CATHETER (K830604)Plasmedics, Inc.1983-07-18
PLASTIC DISPOSABLE RAZOR (K831799)I M, Inc.1983-07-18
CELL-DYN 400 HEMOTOLOGY ANALYZER (K831368)Abbott Diagnostics1983-07-18
QEA SODIUM/POTASSIUM ANALYZER (K832036)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-07-18
DETERM. SIZE 72 RADIAL-HUMAN IGD (K831956)Kent Laboratories, Inc.1983-07-18
WM. HARVEY PARALLEL PLATE MEMBRANE BLOOD (K831705)C.R. Bard, Inc.1983-07-18
EXTERNAL INCONTINENCE CATHETER TAKE-HOME (K832109)Plasco, Inc.1983-07-18
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