Atlas FDA

1983

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

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RecordFirmDate
LARYNGOTELESCOPE CURVED MLC-1 (K832449)Pentax Precision Instrument Corp.1983-09-20
HBO-1 PASS-THROUGH/EXTENSION TUBE (K832434)Nauset Labs1983-09-20
DUAL DIAL VENTURI STYLE MASK (K832725)Airlife, Inc.1983-09-20
EXTENSION CONTROL KNEE ORTHOSIS (K832742)Orthomedics1983-09-20
SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL (K831884)Richards Manufacturer Co.1983-09-20
CATHETER CARE TRAY (K832389)Inmed Corp.1983-09-19
UROTRACK PLUS (K832526)Vital Metrics, Inc.1983-09-19
AMBULATORY MARK XI DRUG INFUSION DEV- (K830657)Windsor Medical, Inc.1983-09-16
EGS MODEL 100-2 (K832370)Electro-Med Health Industries, Inc.1983-09-16
MICRO-STRUCTURED SURFACE HIP PROSTHESIS (K831708)Osteonics Corp.1983-09-15
VENTILATOR #1 (K830488)Ohio Medical Products1983-09-15
INFUSE-A-PORT (K832788)Infusaid Corp.1983-09-15
ACURACY 071, DENTAL, INTRAORAL-X-RAY (K832065)Belmont Equipment Corp.1983-09-12
TRYPTIC SOY BROTH MEDIA (K832620)Carroll Biological Corp.1983-09-12
STERILE SUTURE REMOVAL SET (K832047)Ormed Mfg., Inc.1983-09-12
TRIGLYCERIDE REAGENT-TRINDER-GPO (K832460)Seppim, Inc.1983-09-12
SHERI-I-SLIP INTUBATING STYLET (K832773)Sheridan Catheter Corp.1983-09-12
ANGIO-FLO CONTIN-ARTERIAL FLUSH DEV. (K832058)Parke-Davis Co.1983-09-12
ADJUSTABLE PHARYNGEAL AIRWAY/BERMAN III (K832471)Inmed Corp.1983-09-12
PROTEX CONTRACEPT PLUS W/SPERM-LUB (K831816)National Sanitary Laboratories, Inc.1983-09-12
DISPOSABLE FLOOR INSTRUMENTS (K831911)Ormed Mfg., Inc.1983-09-12
DOWNS ADJUSTABLE FLOW GENERATOR (K831503)Vital Signs, Inc.1983-09-12
VITA-MIST AIR COMPRESSOR & NEBULIZER (K832072)Vita Medics1983-09-12
INDOLE NITRATE MEDIUM (K832568)Acumedia Manufacturers, Inc.1983-09-12
XYLOSE LYSINE DEOXYCHOLATE (K832617)Carroll Biological Corp.1983-09-12
EASYTOUCH TRIGLYCERIDES REAGENT SET (K832426)Worthington Diagnostic Systems1983-09-12
DENTACOLOR LIGHT CURING CROWN & BRIDGE (K831215)Kulzer, Inc.1983-09-12
GAMMA STERIL. CAPILLARY FLOW DIALY-G15 (K832663)Travenol Laboratories, S.A.1983-09-12
ENVISION G21 I/A ENPAK (K832423)Envision, Inc.1983-09-12
SELENITE BROTH (K832614)Carroll Biological Corp.1983-09-12
TWOFER NEEDLE (K832347)Baxa Corp., Sub. of Cook Group, Inc.1983-09-12
BIO SURE STAIN (K832496)Helena Laboratories1983-09-12
INFUSION BROTH (K832569)Acumedia Manufacturers, Inc.1983-09-12
ACETAMINOPHEN(PARACETAMOL (K832567)Bio-Analytics Laboratories, Inc.1983-09-12
ANESTHESIA/RESPIRATORY DISCONNECT - (K831650)Plasmedics, Inc.1983-09-12
BASAL MED. EAGLE #B9888 W/L-GLUTAMINE (K832687)Sigma Chemical Co.1983-09-12
RED COLOR-TINTED TUBING (K832758)Custom Medical, Inc.1983-09-12
SAFETY PINS & RUBBER BANDS (K831915)Ormed Mfg., Inc.1983-09-12
CREATINE KINASE REAGENT CK LTS (K831965)Electro-Nucleonics Laboratories, Inc.1983-09-12
BIRTHWELL BIRTHING SYSTEM (K831998)Qulab Co.1983-09-12
UPSHER FIBERBRITE LARYNGOSCOPE (K832650)Michael S. Upsher1983-09-12
AUTOMATED 8400 BLOOD CELL SEPARATOR (K831004)Intl. Business Machines1983-09-12
LIFECARE MICRO PUMP (K832289)Abbott Laboratories1983-09-12
SERUM HCG ASSAY (K832562)Monoclonal Antibodies, Inc.1983-09-12
PUMPETTE AS8P-INFUSION PUMP (K831534)Travenol Laboratories, S.A.1983-09-12
I.V. TRANSFER NEEDLE (K832312)Baxa Corp., Sub. of Cook Group, Inc.1983-09-12
NEONATAL LUMBAR PUNCTURE TRAY (K832556)American Pharmaseal Div. Ahsc1983-09-12
METABOLIC EXERCISE TESTING SYSTEM (K831780)Warren E. Collins, Inc.1983-09-12
CRONEX LO-DOSE MAMMOGRAPHY (K832504)E.I. Dupont DE Nemours & Co., Inc.1983-09-12
CURITY CATHETER STRAP (K832692)The Kendal Co.1983-09-12
ANDROSTENEDIONE TEST SET 125I (K832452)Wien Laboratories, Inc.1983-09-12
FERTITELL DIRECT PREGNANCY TEST #1100 (K832557)Stanbio Laboratory1983-09-12
BALLOON DILATION HELICAL STONE EXTRACT (K831875)Vpi1983-09-12
ALBUMIN PROCEDURE BCP (K832632)Sandare Chemical Co., Inc.1983-09-12
STERILE DISPOSABLE SYRINGE (K832101)Lee Medical Intl., Inc.1983-09-12
CONVEEN LEG BAG W/TUBE-DRAINAGE BAG (K832537)Telcam Medical Devices, Inc.1983-09-12
NORMAC ANESTHETIC AGENT MONITOR (K832113)Datex Division Instrumentarium Corp.1983-09-12
EMERSON MODEL 3MV-AP AND 3V-AP PRESS- (K832271)J. H. Emerson Co.1983-09-12
BTB LACTOSE AGAR (K832574)Acumedia Manufacturers, Inc.1983-09-12
AIR SHIELDS AS-100 MONIORING SYS-AS105 (K831430)Narco Scientific1983-09-12
INFUSION SETS #'S 124 & 142 PERSONAL (K831445)Pacesetter Systems1983-09-12
T3-RIA SINGLE REAGENT (K832469)Fairlake Laboratories1983-09-12
MCCOY'S 5A #M4892 W/L-GLUTAMINE AND (K832689)Sigma Chemical Co.1983-09-12
BIO-TEK PERCENT OXYGEN MONITOR 74222 (K831522)Bio-Tek Instruments, Inc.1983-09-12
SEED AGAR (K832577)Acumedia Manufacturers, Inc.1983-09-12
MONOJECT INJECTOMATIC (K832683)Sherwood Medical Co.1983-09-12
TECHNICON H6000 SYSTEM (K832627)Technicon Instruments Corp.1983-09-12
CIN AGAR (K832588)Laboratory Products, Inc.1983-09-12
URODYNAMIC ANALYZER (K831788)C.R. Bard, Inc.1983-09-12
FEMORAL CANAL SPONGE (K831886)Zimmer, Inc.1983-09-12
AUTOPAK NEONATAL TSH RIA KIT (K832462)Micromedic Systems1983-09-12
ALT -LTS (K832639)Electro-Nucleonics Laboratories, Inc.1983-09-12
MACCONKEY AGAR MEDIA (K832616)Carroll Biological Corp.1983-09-12
BIOFLOW (K831422)Bomed Medical Mfr., Ltd.1983-09-12
ENDOSCOPIC CAMERA TV W/AUDIO (K832342)Kamiya Tsusan Kaisha, Ltd.1983-09-12
DISPOSABLE NEEDLE HOLDER (K831665)Medcare Products1983-09-12
DISCO SUNGLASSES/HEADBAND SUNGLASSES (K832564)E-Tay Industrial Co. , Ltd.1983-09-12
ADMINISTRATIVE IV SET (K832105)Lee Medical Intl., Inc.1983-09-12
TRUST RPR TITRATION CARD TEST #65145 (K832480)Emd Chemicals, Inc.1983-09-12
CORTISOL RADIOIMMUNOASSAY KIT (K832638)Bioclinical Group1983-09-12
BASE AGAR (K832576)Acumedia Manufacturers, Inc.1983-09-12
CLINAC 1800 (K832503)Varian Assoc., Inc.1983-09-12
EXTRACT BROTH (K832570)Acumedia Manufacturers, Inc.1983-09-12
GERBER PRECISION CARE BREAST PUMP (K832597)Gerber Products Co.1983-09-12
THEOPHYLLINE TEST PACK ACA (K831934)E.I. Dupont DE Nemours & Co., Inc.1983-09-12
BLUE AGAR (K832618)Carroll Biological Corp.1983-09-12
A-GENT CARBAMAZEPINE (K832631)Abbott Laboratories1983-09-12
OHIO TEMPERATURE SIMULATOR (K832418)Airco/Ohio Medical Products1983-09-12
RAICHEM ALKALINE PHOSPHATASE REAGENT (K832463)Reagents Applications, Inc.1983-09-12
A-GENT PHENOBARBITAL (K832457)Abbott Laboratories1983-09-12
TRYPTIC SOY AGAR (K832611)Carroll Biological Corp.1983-09-12
MANNITOL SALT AGAR (K832613)Carroll Biological Corp.1983-09-12
PHASE II TSH KIT (K832499)Medical & Scientific Designs, Inc.1983-09-12
DENTURE CLEANER (K832387)Tower Laboratories, Ltd.1983-09-12
GRASEBY DYNAMICS MS302 SYRINGE DRIVER (K832410)Intermedics, Inc.1983-09-12
A.V.R. KNEE LENGTH THERAPEUTIC STOCK- (K832609)The Kendal Co.1983-09-12
ANTIBIOTIC ASSAY BROTH (K832575)Acumedia Manufacturers, Inc.1983-09-12
STERILE DISP. BUTTERFLY INFUSION SET (K832104)Lee Medical Intl., Inc.1983-09-12
VARIAN CLINACOMP 100 TISSUE COMPENSATOR (K832216)Varian Assoc., Inc.1983-09-12
TRUST RPR CARD TEST #65144 (K832479)Emd Chemicals, Inc.1983-09-12
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Every clearance here is in the API, with alerts when new ones post.