Atlas FDA

1984

4,397 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SALICYLATE ASSAY KIT (K842158)Diagnostic Chemicals, Ltd. (Usa)1984-10-22
MEA110 (K843822)Canadian Medical Products1984-10-22
UNIVERSAL BY RUSH-HAMPTON ARTHROSCOPIC (K843282)Rush Hampton Industries1984-10-22
TSH RECEPTOR ANTIBODY KIT 125I TSH (K841580)Clinetics Corp.1984-10-22
AUTODYNAMIC COMPRESSION HIP SCREW-PLATE (K843449)Mecron Medical Products, Inc.1984-10-22
MEDICA IIF-ANTI-THYROID ANTIBODY TEST (K843343)Medical Diagnostics, Ca.1984-10-22
RICHARD ARTHROSCOPE (K843604)Richards Medical Co., Inc.1984-10-22
MOLINEA INCONTINENT PAD (K843404)Paul Hartmann Corp.1984-10-19
MINISET VEIN INFUSION SETS (K843631)Travenol Laboratories, S.A.1984-10-19
LS-260G MONITOR/RECORDER & DEFIBILLATOR (K843396)Life Science Instrumentation, Inc.1984-10-19
EMPTY SOLUTION TRANSFER CONTAINER (K842170)The Healthcare Group Laboratories, Inc.1984-10-19
DOUBLE CONTOURED CUFF TRACHEAL TUBE (K843714)Ohmeda Medical1984-10-19
VF-PD-120 (K842460)Valpey-Fisher Corp.1984-10-19
MOLICARE (K843405)Paul Hartmann Corp.1984-10-19
WET-STOP (K842547)Palco Laboratories, Inc.1984-10-19
THERMAL GRAYSCALE RF-100 (K843836)Fukuda Denshi USA, Inc.1984-10-19
SHILEY DISPOS. CANNULA FENESTRATED LOW (K843729)Shiley, Inc.1984-10-19
UROPUMP MODEL 1711 (K843224)Life-Tech Intl., Inc.1984-10-19
CARDIO METRIC CUSTOM PERFUSION TUBING (K841959)Sterile Design, Inc.1984-10-19
MODULAR VOLUMETRIC INFUSION PUMP SYS (K843274)American Edwards Laboratories1984-10-19
SHILEY DISPOS. DECANNULATION PLUG W/SW/ (K843730)Shiley, Inc.1984-10-19
RADIONUCLIDE INFUSION SYSTEM (K842568)Squibb Diagnostics1984-10-19
CARDIOSCAN - TM BEING APPLIED FOR (K841263)Interspec, Inc.1984-10-19
INTERCEPT (K843591)Vital Signs, Inc.1984-10-19
MOLINEA PANTY (K843403)Paul Hartmann Corp.1984-10-19
AMER. BENTLEY HEMOFILTER HOLDER HFH-1 (K843504)American Bentley1984-10-18
FLOW-DIRECTED THERMODILUTION CATH (K843409)Andover Medical, Inc.1984-10-18
AMER. BENTLEY CONTINU-BLOOD PROCESSOR- (K841585)American Bentley1984-10-18
SPACELABS ALPHA PC PATIENT COMPUTER (K842616)Spacelabs, Inc.1984-10-18
PO 2 LYTRODE (K843538)Polystan C/O Vitalcor, Inc.1984-10-18
HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS (K842829)North American Instrument Corp.1984-10-18
LIFEPAK 200 (K843229)Physio-Control Corp.1984-10-18
FRENCH 7 TRI-ACCESS COMPACT CENTRAL VEIN (K843500)Cardio-Vascular Innovations, Inc.1984-10-18
ELECTRODE CATHETER, ORTHOGONAL TYPE (K841802)Webster Laboratories, Inc.1984-10-18
AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE (K842481)American Edwards Laboratories1984-10-18
ORTHOMITE 111 ADHESIVE (K843527)Rocky Mountain Orthodontics, Inc.1984-10-18
TWO COMPONENT RTV VINYL SILICONE MATER (K843145)Crown Delta Corp.1984-10-18
EMA FREEGENOL DENTAL CEMENT (K842994)Int'L Corp.1984-10-18
HOLLOW FIBER DIALYZER (K843632)Travenol Laboratories, S.A.1984-10-18
OHMEDA ANESTHESIA RECORD KEEPER (K844012)Ohmeda Medical1984-10-18
SINGLE WALL INTRODUCER NEEDLE (K843719)Ocean Medical Products, Ltd.1984-10-18
INFRARED COAGULATOR (K842810)Endo Lase, Inc.1984-10-18
ARGYLE SILICONE LEFT VENTRICULAR AND (K843444)Sherwood Medical Co.1984-10-18
VAPOR-PHASE HUMIDIFIER SYS-ADVANCED (K843932)Inspiron Corp.1984-10-18
THERMAL DILUTION CATHETER (K843411)Andover Medical, Inc.1984-10-18
EXTENDED LIFE CAPD SOLUTION TRANSFER (K842885)Travenol Laboratories, S.A.1984-10-18
LIFEPAK 8 (K842624)Physio-Control Corp.1984-10-18
ARRHYTHMIA CENTRAL OCC-7101 (K843287)Nihon Kohden America, Inc.1984-10-18
PEDIATRIC DIAG. CRITERIA OPTION 5600C (K841416)Hewlett-Packard Co.1984-10-18
PHARMA-PLAST CONNECTING TUBE TYPE URIN- (K843481)Zimmar Consulting , Ltd.1984-10-18
NAMIC ADB ANGIOGRAPHIC DUMP BAG (K843726)North American Instrument Corp.1984-10-18
SHILEY CORONARY CARDIOPLEGIA ADAPTOR (K843542)Shiley, Inc.1984-10-18
FRESENIUS HAEMODIALYSIS A2008 (K843014)Seratronics, Inc.1984-10-18
ULTRACLONE ECL-01-900 CELL LINE (K843862)Earl-Clay Laboratories, Inc.1984-10-17
ANALOX LM3 MICRO-STAT ANALYSER (K843082)Analox Instruments , Ltd.1984-10-17
ULTRACLONE ECL-01-1300 CELL LINE (K843863)Earl-Clay Laboratories, Inc.1984-10-17
COBAS-FIBRO (K842717)Roche Diagnostic Systems, Inc.1984-10-17
ULTRACLONE ECL-01-1400 CELL LINE (K843864)Earl-Clay Laboratories, Inc.1984-10-17
DOUMENT TM LINEARITY TEST STANDARDS (K843947)Casco Standards1984-10-17
ENZYGNOST ROTAVIRUS AG (K841243)Behring Diagnostics, Inc.1984-10-17
ASTRA 2, ASTRA 3, 4 & 6 (K842394)Cardiac Pacemakers, Inc.1984-10-17
TOXOPLASMA GONDII IGM EIA TEST KIT (K842797)Labsystems, Inc.1984-10-17
MEDTRONIC 5984-5984LP-5985 (K843837)Medtronic Vascular1984-10-17
DACOS PLUS LYTES OPTION (K843239)Coulter Electronics, Inc.1984-10-17
EMPTY SOLUTION TRANSFER CONTAINER 1000 (K843523)Polymer Technology Corp.1984-10-16
TETRAFLEX INTEGRALLY SUPPORTED PTFE (K831822)Shiley, Inc.1984-10-16
PNEUMOSCREEN (K843849)Erich Jaeger, Inc.1984-10-16
EXTENSION SET W/INJECTION SITE (K842984)Med Fusion Systems, Inc.1984-10-16
UNIFLEX DANNINGER (K843309)Buckman Co., Inc.1984-10-16
RIA PANTY SHIELDS (K843401)Paul Hartmann Corp.1984-10-15
HOLLOW BASKET DENTAL IMPLANTS (K843217)Artech Corp.1984-10-15
LAURIER SANITARY NAPKIN (K843318)Kao Corp.1984-10-15
GLYCO-TEK AFFINITY COLUMN (K842689)Helena Laboratories1984-10-15
SAFE & SOFT MAXI SHILEDS (K842837)Ipco Corp.1984-10-15
PERCUTANEOUS CRICOTHYROIDOTOMY (K822440)Frederic J. Toye, M.D.1984-10-15
CARDIO METRICS CARDIOTOMY RESERVOIR (K841958)Sterile Design, Inc.1984-10-15
SAFE & SOFT MINI PADS & MAXI PADS (K842836)Ipco Corp.1984-10-15
LIVER BIOPSY TRAY (K842001)Jayco Pharmaceuticals1984-10-15
STERILE DESIGN-CUSTOM STERILE IV KIT (K842351)Sterile Design, Inc.1984-10-15
PERCUTANEOUS BALLOON (K832753)Smec, Inc.1984-10-13
ACT, SUCTION TIP (K842779)Edward Manougian, M.D.1984-10-12
INTRAUTERINE DEVICE REMOVER (K842295)Premier Dental Products Co.1984-10-12
BEMCO PORTABLE OXYGEN INHALATOR (K843585)Bemco, Inc.1984-10-12
MICROSPAN -PH MONITOR (K842303)Biochem International, Inc.1984-10-12
N2 TEST (K843840)Erich Jaeger, Inc.1984-10-12
CO2 TEST (K843844)Erich Jaeger, Inc.1984-10-12
A-T TENS BELT (K843793)A-T Surgical Mfg. Co., Inc.1984-10-12
O2 TEST (K843847)Erich Jaeger, Inc.1984-10-12
CO TEST (K843845)Erich Jaeger, Inc.1984-10-12
TRIGLYCERIDE ASSAY KIT GPO-CP (K843536)Diagnostic Chemicals, Ltd. (Usa)1984-10-11
PHARMA-PLAST LEG BAG (K843479)Zimmar Consulting , Ltd.1984-10-11
PHENYTOIN ACA ANALYTICAL TEST PACK (K843209)E.I. Dupont DE Nemours & Co., Inc.1984-10-11
DAVOL GAUDERER-PONSKY PERCUTAN-ENDOSCOP (K843305)C.R. Bard, Inc.1984-10-11
APPARATUS, SUCTION, WARD USE, PORTAB- (K843750)H.C.H. Products, Inc.1984-10-11
GASTRIN RADIOIMMUNOASSAY TEST KIT (K842965)Serono Diagnostics, Inc.1984-10-11
URI TX-100 MULTICHANNEL THERMOCOUPLE (K843381)Uri Therm-X, Inc.1984-10-11
ATAC 2000 (K843059)Turpen Laboratory Systems, Inc.1984-10-11
PHARMA-PLAST URINARY DRAINAGE BAG 2000 (K843480)Zimmar Consulting , Ltd.1984-10-11
ENCORE TSH REAGENT (K843395)Hybritech, Inc.1984-10-11
ALBUMIN REAGENT SET (K843831)Livonia Diagnostics, Inc.1984-10-11
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Track 1984 automatically

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