Atlas FDA

1984

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

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RecordFirmDate
MODEL 3014 SUCTION UNIT (K841631)Forma Scientific, Inc.1984-07-03
UTERINE INJECTOR 4.0MM (K841682)Humi Corp.1984-07-03
NEUROMEDICS ULTRASTIM 650-01 (K841647)Intermedics, Inc.1984-07-03
FALL-SAFE VEST (K841672)Fsm Corp.1984-07-03
CEMENTLESS HIP PROSTHESIS (K840271)Mecron Medical Products, Inc.1984-07-03
DENTAL COTTON ROLLS (K841327)Intl. Verbandstoff-Fabrik Schaffhau1984-07-03
MULTICHANNEL 2000 FLUOROPTIC THERMOMET (K841105)Luxtron1984-07-03
LYFO-DISK MICROORGANISMS (K842129)Micro-Bio-Logics1984-07-03
SPOTTEST LACTOPHENOL COTTON BLUE STAIN (K842086)Difco Laboratories, Inc.1984-07-03
FALL-SAFE MONITOR (K841671)Fsm Corp.1984-07-03
DISPOS. POLY APRONS (K842016)Abco Dealers, Inc.1984-07-03
SECURA SET (K841859)Diatek, Inc.1984-07-03
PATHO DX LATEX AGGLUTINATION STREP A (K842383)Diagnostic Products Corp.1984-07-02
VENTRESCREEN STREP A TEST (K842239)Ventrex Laboratories, Inc.1984-07-02
ACS SOF-T GUIDE WIREE (K840795)Advanced Cardiovascular Systems, Inc.1984-07-02
IDI ISOTONIC DILUENT (K842068)Interscience Diagnostics, Inc.1984-07-02
IDD DETERGENT (K842070)Interscience Diagnostics, Inc.1984-07-02
GENERAL DIAGNOSTICS PLATELET ANTIBODY (K841465)General Diagnostics1984-07-02
ARK TONGUE CLEANER (K841077)Arkay Co.1984-07-02
10.5 FRENCH DILATOR, 15CM, W/LUER LOCK (K841995)Quinton, Inc.1984-07-02
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE (K842457)Pharmacia, Inc.1984-07-02
IDL-LYSING REAGENT (K842069)Interscience Diagnostics, Inc.1984-07-02
BIOTIS LD-PRESUMPTO QUADRANT PLATE (K842424)Otisville Biotech, Inc.1984-07-02
BIOTIS N.Y.C. CARBOHYDRATE FERMENTA- (K842400)Otisville Biotech, Inc.1984-07-02
STERILE O.R. BASIN KIT PRODUCT LINE (K841484)Medline Industries, Inc.1984-07-02
CARDIO EXPRESS 100 HOLTER SCANNER (K840622)Del Mar Avionics1984-07-02
RIM STREP KIT (K842451)Austin Biological Laboratories1984-07-02
SKYNDEX ELECTRONIC BODY FAT CALCULA (K841687)Caldwell, Justiss & Co., Inc.1984-06-28
PRESSURE RELIEF SEAT CUSHION (K842380)American Pharmaseal Div. Ahsc1984-06-28
VASCULAR-ACCESS-PORT WITHDRAWL-BLOOD (K841679)Norfolk Medical Products, Inc.1984-06-28
DIALYSATE ADDITIVES (K842294)Dialysis Products, Inc.1984-06-28
CRITIKON I.V. FILTER (K842075)Critikon Company, LLC1984-06-28
MEDILOG PH1 (K840934)Oxford Medilog, Inc.1984-06-28
PARA THERM BATH (K842423)Grimm Scientific Industries, Inc.1984-06-28
PIRD-Y (K842262)Pirdy, Inc.1984-06-28
ENDOPORT EROCAR (K841716)Endotherapeutics1984-06-28
INTRAVASCULAR CATHETER SECUREMENT DEV (K841487)Tapemark Co.1984-06-28
ARGYLE ENTERNAL FEEDING BAG W/ADMIN (K840877)Sherwood Medical Co.1984-06-28
THINWALL PUNCTURE NEEDLE (K841704)Meadox Surgimed, Inc.1984-06-28
IMR-90-DIPLOID-HUMAN FETAL LUNG CELL (K841998)Bartels Immunodiagnostic Supplies, Inc.1984-06-27
MONTGOMERY LARYNGEAL STENT (K842287)Boston Medical Products, Inc.1984-06-27
OTICON E28A (K841436)Oticon Corp.1984-06-27
AUDIOMETER MA728 (K841567)Maico Hearing Instruments, Inc.1984-06-27
STELDENT - DENTAL ALLOY (K841290)Eriez1984-06-27
RESTODENT DENTIN BONDING AGENT (K840726)Lee Pharmaceuticals1984-06-27
ALINE ORTHODONTIC ARCHWIRE (K841638)A Company, Inc.1984-06-27
EXACTA-FILM (K842512)Ardent Intl., Inc.1984-06-27
FORMA-FAS-TEST (K833128)Chemical Detection & Experimentation1984-06-27
GLATTELAST COMPRESSION PANTY HOSE (K841252)Baurs Krey Assoc., Inc.1984-06-27
VENTRAL WALL DEFECT REDUCT SILO (K840172)American Heyer Schulte1984-06-27
DEMLAR SYS I COMPUTER BASED AUDIOMETER (K841167)Demlar Medical, Inc.1984-06-27
FLOSS N' GLOSS/SAFETY FLOSS MED DEVICE (K841675)Leonard Lorch1984-06-27
FUZZY TRAY (K841323)Buffalo Dental Mfg. Co., Inc.1984-06-27
POLYSULFIDE CUSTOM TRAY MATERIAL (K841490)Buffalo Dental Mfg. Co., Inc.1984-06-27
ZINC DUST SUSPENSION (K842299)Irvine Diagnostic Services1984-06-26
PULSE GENERATOR 688B & 688L (K841231)Siemens Elema AB1984-06-26
SPIROTECH ST-550 (K840972)Spirotech, Inc.1984-06-26
PENLON TRANSPORT VENTILATOR SERIES 350 (K842362)Bear Medical Systems, Inc.1984-06-26
PARA 4 (K842017)Streck Laboratories, Inc.1984-06-26
GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY (K842079)Immuno Nuclear Corp.1984-06-26
PULSE GENERATOR 718B & 718L (K841228)Siemens Elema AB1984-06-26
WAKO B.G. PRETEST STRIPS (K842207)Healthdyne, Inc.1984-06-26
AVATRON DISPOSABLE I.P.P.B. CIRUCIT (K842389)Avatron, Inc.1984-06-26
PENLON ANESTHESIA VENTILATOR SERIES 300 (K842363)Bear Medical Systems, Inc.1984-06-26
UNIMACS, PATENT PENDING UNIVERSAL MAM (K841774)Technical Devices For Medicine1984-06-26
MELOY AUTOANTIBODY TEST SYS (K842247)Meloy Laboratories, Inc.1984-06-26
PARAPLAST EXTRA TISSUE EMBEDDING MED. (K842053)Sherwood Medical Co.1984-06-26
MODEL 4000 MD-YAG LASER FOR MALIGNANT (K842412)Cooper Lasersonics, Inc.1984-06-26
CAPNOMETER (K842325)Sensors, Inc.1984-06-26
SPIROMATE AS-500 (K842372)Riko Medical & Scientific Instrument Corp.1984-06-26
PULSE GENERATOR 728, 728B & 728L (K841226)Siemens Elema AB1984-06-26
ORTHO VARICELLA-ZOSTER VIRUS IDENT. (K841526)Ortho Diagnostic Systems, Inc.1984-06-25
PULSE GENERATOR 698, 698B & 698L (K841229)Siemens Elema AB1984-06-25
SIGMA PROCEDURE 47-UV (K842013)Sigma Chemical Co.1984-06-25
OXIDASE TEST STRIPS-OXIDASESURE (K842298)Irvine Diagnostic Services1984-06-25
THYROXINE-BINDING GLOBULIN RADIOUMMU (K842010)Nichols Institute Diagnostics1984-06-25
OXY-VAC (K842205)Medi-Tech, Inc.1984-06-25
CROUP TENT FRAME (K842192)Home Run Treadmill Co.1984-06-25
PULSE GENERATOR KALOS-04 (K841950)Biotronik Sales, Inc.1984-06-25
NEOS M (K841636)Biotronik Sales, Inc.1984-06-25
TESTOSTERONE DIRECT RADIOIMMUNOASSAY (K841948)Sorin Biomedica, Fiat, USA, Inc.1984-06-25
VITAMIN B12 57CO/FOLATE 125I - (K840462)Corning Medical & Scientific1984-06-25
PENNSYLVANIA HOSPITAL HIP SYS (K841437)Biomet, Inc.1984-06-25
SRC TOTAL KNEE (K841022)Joint Medical Products Corp.1984-06-25
C.A.P.D. AUTOMATIC HEATER PDH 200 (K842305)Medionics International , Ltd.1984-06-25
ENZYMATIC ACETAMINOPHEN ASSAY (K841930)Diagnostic Chemicals, Ltd. (Usa)1984-06-25
T3 UPTAKE (K841927)Syncor Intl. Corp.1984-06-25
GASTRIN RIA (K841963)Syncor Intl. Corp.1984-06-25
DUPONT ACA MAGNESIUM CALIBRATOR (K841955)E.I. Dupont DE Nemours & Co., Inc.1984-06-25
AMER. PHARMASEAL NO TOUCH SATIN CATHET (K842198)American Pharmaseal Div. Ahsc1984-06-25
LYRIS MODULAR INFO SYSTEM (K831830)Biovation, Inc.1984-06-25
ULTRAMAX (K832705)Medicorp, Inc.1984-06-25
DOUBLE LUMEN SUBLCAVIAN-FEMORAL (K841530)Medical Components, Inc.1984-06-25
BX-400 (K842142)Bloomex International, Inc.1984-06-25
ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT (K841947)Sorin Biomedica, Fiat, USA, Inc.1984-06-25
HL-1, DEFINED SERUM FREE MEDIA (K841993)Ventrex Laboratories, Inc.1984-06-25
FILTRYZER HOLLOW FIBER ARTIF. KIDNEY (K831175)Erika, Inc.1984-06-22
FILTRYZER HOLLOW FIBER ARTIF. KIDNEY (K831176)Erika, Inc.1984-06-22
SPOT TEST NINHYDRIN REAGENTS (K842290)Difco Laboratories, Inc.1984-06-22
FLAME PHOTOMETERS (K834226)Dr. Bruno Lange GmbH1984-06-22
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