Atlas FDA

1985

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

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RecordFirmDate
KATENA MICROMETER KNIFE W/XTAL BLADE OF CRYSTAL SA (K850049)Xtal Corp.1985-03-06
CARDIO ANALYZER MODEL 380 (K844104)Birtcher Corp.1985-03-06
MEDTRONIC 5061 ENDOCARDIAL PACING LEAD (K844974)Medtronic Vascular1985-03-06
PEEL-AWAY INTRODUCER SET (K844693)Quinton, Inc.1985-03-06
ELECATH CARDIAC OUTPUT COMPUTER (K844682)Electro-Catheter Corp.1985-03-06
INTRA-ARC DISPOSABLE ARTHROPLASTY BURRS (K850645)Concept, Inc.1985-03-06
KM PRODUCTS SUCTION TIPS (K850240)Km Products1985-03-06
THE MEHESZ STIMULATING SYSTEM (K844994)Campden Medical , Ltd.1985-03-06
ACCU-O-MATIC (K841427)Myomed, Inc.1985-03-05
PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU (K844135)Immuno Nuclear Corp.1985-03-05
CFE ACETABULAR CUP (K844941)Biomet, Inc.1985-03-05
DU PONT DIGOXIN ASSAY CALIBRATOR (K850457)E.I. Dupont DE Nemours & Co., Inc.1985-03-05
TSH-STAT (K844583)Nuclear Medical Laboratories, Inc.1985-03-05
ENZYMATIC ALPHA-AMYLASE REAGENT KIT (K850639)Bio-Analytics Laboratories, Inc.1985-03-05
ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM (K850298)Cabot Medical Corp.1985-03-05
HANKS' MEM W/NON-ESSENTIAL AMINO ACIDS POWDER MED- (K850222)Hazleton Research Products, Inc.1985-03-05
ECHO TYPE 9 CF ANTIGEN (K844967)Hillcrest Biologicals1985-03-05
CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS (K850131)Consolidated Medical Equipment, Inc.1985-03-05
PRECINORM H & PRECIPATH H (K850017)Boehringer Mannheim Corp.1985-03-05
SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN (K850603)Applications Lab1985-03-05
THREADED TITANIUM METAL BACKED ACETABULAR CUP (K844906)Depuy, Inc.1985-03-05
WAYMOUTH'S MEDIUM MB 752/1 (K850224)Hazleton Research Products, Inc.1985-03-05
ECHO TYPE 4 CF ANTIGEN (K844695)Hillcrest Biologicals1985-03-05
ELECTRONIC MUSCLE STIMULATOR (K844489)Beverly Hills Exercise Equipment1985-03-05
TRI-COUNT CALIBRATOR (K844708)Hematology Marketing Assoc.1985-03-05
SPORDEX CULTURE MEDIA (K850143)American Sterilizer Co.1985-03-05
ARTISAN FOLDING WHEELCHAIRS (K844799)Artisan Wheel Chair Manufacturers1985-03-05
SPQ TEST SYSTEM FOR TRANSFERRIN (K850589)Applications Lab1985-03-05
ANAEROBE KIT (K850052)Austin Biological Laboratories1985-03-05
LIQUI-HEME HEMOGLOBIN CALIBRATORS (K842668)Biodiagnostic Intl1985-03-05
SPQ TEST SYSTEM FOR HAPTOGLOBIN (K850584)Applications Lab1985-03-05
DUPONT DIGOXIN ASSAY REAGENTS (K850458)E.I. Dupont DE Nemours & Co., Inc.1985-03-05
RPMI-1603 MEDIUM (K850229)Hazleton Research Products, Inc.1985-03-05
ISOCONTROL SERUM CK-MB (K850213)Sclavo, Inc.1985-03-05
BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE (K845008)Marion Laboratories, Inc.1985-03-05
QBC CENTRIFUGAL HEMATOLOGY ANALYZER (K844645)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-03-05
OVU STICK SELF-TEST -MODIFICATION (K850480)Monoclonal Antibodies, Inc.1985-03-05
ALPHA MEM W/NUCLEOSIDES POWDER MEDIUM (K850221)Hazleton Research Products, Inc.1985-03-05
ACCESS C (K843911)Advanced Technology Laboratories, Inc.1985-03-05
DESERET EPIDURAL CATHETER (K850439)Parke-Davis Co.1985-03-05
NSI ELT-D DILUTING FLUID 4000ML (K844782)Nobel Scientific Industries, Inc.1985-03-05
MODELS 841,842,843,851,852 & 853 ELEVATING TRACTIO (K844712)Tri W-G, Inc.1985-03-05
ALPHA MEM MEDIUM W/O NUCLEOSIDES (K850231)Hazleton Research Products, Inc.1985-03-05
COXSACKIE B SERIES CF ANTIGENS (K850003)Hillcrest Biologicals1985-03-05
NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG (K850079)Bioclinical Systems, Inc.1985-03-05
SPQ TEST SYSTEM FOR COMPLEMENT C3 (K850588)Applications Lab1985-03-05
SANYO ELECTRONIC MUSCLE STIMULATORS (K850047)General Physiotherapy, Inc.1985-03-05
MAYO ELBOW II (K843778)Zimmer, Inc.1985-03-05
ABSORBABLE GAUZE PRODUCTS (K844573)Medicon, Inc.1985-03-05
CHLAMYDIA GROUP CF ANTIGEN (K844868)Hillcrest Biologicals1985-03-05
GLUCOSE - TRINDER- REAGENT (K850364)Sigma Chemical Co.1985-03-05
MODELS 134, 135 & 136 TRANSFER CART/TABLE (K844711)Tri W-G, Inc.1985-03-05
LEUCINE AMINOPEPTIDASE REAGENT (K844965)Alladin Diagnostic, Inc.1985-03-05
WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D (K850359)Millipore Corp.1985-03-05
NEBULIZER TREATMENT KIT (K850320)Dhd Medical Products Div. Diemolding Corp.1985-03-05
RPMI-1634 MEDIUM (K850230)Hazleton Research Products, Inc.1985-03-05
DISPOS. CONDUCTIVE ADHESIVE TENS PAD (K850311)Consolidated Medical Equipment, Inc.1985-03-05
OPERAID DISPOS. IRRIGATING KNIFE (K845039)Jedmed Instrument Co.1985-03-05
EXCEL TECH MST-7 ISOELECTRONIC THERAPY DEVICE (K844617)Excel Tech. , Ltd.1985-03-05
BCS GLUCOSE COLORIMETRIC TEST (K850257)Bioclinical Systems, Inc.1985-03-05
LEECO CONCEP-7-BHCG LEIAD II (K850201)Leeco Diagnostics, Inc.1985-03-04
TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT (K850159)Hybritech, Inc.1985-03-04
HI-LO TEMP THERMOCOUPLE TO THERMISTER ADAPTOR (K844201)Mallinckrodt Critical Care1985-03-04
SUCTION REGULATOR 7700 SERIES (K850200)Boehringer Laboratories1985-03-04
FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES (K844346)Fisher Diagnostics1985-03-04
EMEM W/NEAA-MINIMUM ESSENTIAL MED. W/NON-ESS. AMIN (K850510)Mediatech, Inc.1985-03-04
TROGIDE (K844696)Carmel Medical Devices1985-03-04
DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU (K850191)Bio-Rad1985-03-04
TERUMO SENSIBEAD EIA TSH KIT (K850376)Terumo Medical Corp.1985-03-04
CHLAMYDIAL TRANSPORT MEDIA (K850124)Hillcrest Biologicals1985-03-04
DIRECT BILIRUBIN FOR DEMAND ANALYZER (K850379)Advanced Biomedical Methods, Inc.1985-03-01
CALCULATING CUFF INFLATOR TD312 (K842067)D. E. Hokanson, Inc.1985-03-01
BRENTWOOD EZ SCAN 200 AMBULATORY ECG (K842976)Brentwood Instruments, Inc.1985-03-01
TOMOGRAPHIC GANTRY (K844218)General Electric Co.1985-03-01
OSMOLARITY STANDARDS (K844589)Rna Medical Corp.1985-03-01
H/G CUP POSITIONER (1520) LEFT-500PCS RIGHT 500PCS (K850502)The Huxley Instrument Corp.1985-03-01
DISPOSABLE ECG ELECTRODE (K841944)Bristol Medical Electronics Corp.1985-03-01
EDEC-100 (K843443)Electromed Intl., Ltd.1985-03-01
PHONOANGIOGRAPHIC SPECTRAL ANALYZER (K840169)Biotronics Instruments1985-03-01
KOTEX THIN MAXI PADS (K850034)Kimberly-Clark Corp.1985-03-01
PRL QUIK RIA KIT (K850383)Pacific Biotech, Inc.1985-03-01
ACOUSTIC OTOCOPE RECORDER (K850007)Endeco Medical, Inc.1985-03-01
ADAC MODEL DPS-3300M DIGITAL PROCESSING SYSTEM (K844298)Adac Laboratories1985-03-01
DIGITAL FLUOROGRAPHIC IMAGING SYSTEM DIGIFORMER (K844037)Toshiba Medical Systems1985-03-01
RICO RS-6X EMERGENCY MEDICAL ASPIRATOR (K844882)Rico Suction Laboratories, Inc.1985-03-01
MAGNESIUM REAGENT FOR DEMAND ANALYZER (K850381)Advanced Biomedical Methods, Inc.1985-03-01
IMA-TROL IMMUNOASSAY CONTROL (K844848)Dimension Diagnostics1985-03-01
PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL (K850207)Syncor Intl. Corp.1985-03-01
COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM (K850656)Cook Pacemaker Corp.1985-03-01
MONITORING SYSTEM M720 (K842944)Burdick Corp.1985-03-01
RICO RS4-XP EMERGENCY MEDICAL ASPIRATOR (K844881)Rico Suction Laboratories, Inc.1985-03-01
ECG PATIENT MONITOR 302 (K850155)Rigel Medical Electronics, Inc.1985-03-01
ABBOTT RF EIA DIAGNOSTIC KIT (K850373)Abbott Laboratories1985-03-01
SPQ TEST SYSTEM FOR COMPLEMENT C4 (K850585)Applications Lab1985-03-01
ELECTROCARDIOGRAM DISPOS. ELECTRODE PAD (K842514)Multi Biosensors, Inc.1985-03-01
KOTEX MAXI PADS (K850033)Kimberly-Clark Corp.1985-03-01
SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G (K850583)Applications Lab1985-03-01
ACCUTORR CSM SYSTEM (K842538)Datascope Corp.1985-03-01
SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY (K850660)Suntech USA, Inc.1985-03-01
LISTER BANDAGE SCISSORS (6-0064)-4.5 500PCS. (K850501)The Huxley Instrument Corp.1985-03-01
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Track 1985 automatically

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