Atlas FDA

1984

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

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RecordFirmDate
INJECTION NEEDLE (K834403)Bobbs Medical, Inc.1984-02-04
RADIOIMMUNOASSAY, THYROID STIMU. HORMONE (K833193)Biosan Laboratories, Inc.1984-02-04
TWO CHANNEL GASTROFIBERSCOPE FG-36T (K833924)Pentax Precision Instrument Corp.1984-02-04
MAHURKAR DUAL LIMEN FEMORAL CATHETER (K834109)Quinton, Inc.1984-02-04
DART GAMMA-GT REAGENT SYSTEM (K834054)Coulter Electronics, Inc.1984-02-04
HODGE DECOMPRESSION TUBE (K834258)Inmed Corp.1984-02-04
BLOOD TUBING (K834596)Renal Systems, Inc.1984-02-04
INJECTION CAP (K834480)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-02-04
PROGESTERONE TEST SET 125I 17-OH (K834246)Wien Laboratories, Inc.1984-02-04
COAGULATION FACTOR DEFICIENT PLASMA (K840114)Medical Specialties Laboratories1984-02-04
COAXIAL BALLOON GASTROESOPHAGEAL DILA (K834451)Thomas J. Fogarty, M.D.1984-02-04
OVERHEAD WHIRLPOOL HAND SPA BRAND (K840282)Priest Enterprises, Inc.1984-02-04
SIMPLEX-2 (K832541)Gentech Australia1984-02-04
TRANS-PACE (K834262)Micromedical Devices, Inc.1984-02-04
PROTOPATH FACTOR VIII ASSAY (K834051)American Dade1984-02-04
NEPHROSTOMY/BILIARY DRAINAGE BAG (K834476)Vertex Medical Corp.1984-02-04
OCULASE 514 OPHTHALMIC ARGON LASER (K833532)Lasermed Corp.1984-02-04
SOFTIP CATHETER (K834275)Angiomedics, Inc.1984-02-04
PRESERV SAF FIXATIVE 15ML (K834566)Preventive Diagnostics Corp.1984-02-04
STERILE LABELS (K834062)Devon Industries, Inc.1984-02-04
HEMOFILTRATION SYSTEM (K831784)Gambro, Inc.1984-02-04
AUTOTECHNICON V TISSUE PROCESS SYS (K834599)Technicon Instruments Corp.1984-02-04
MATCHED COMPONENT SET FOR DIGITOXIN (K834080)Cambridge Medical Technology1984-02-04
CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV (K840313)Imm Enterprises , Ltd.1984-02-04
SOUND IMAGER I (K833231)Sound Imaging, Inc.1984-02-04
NITROGLYCERINE CONTAINER (K833311)Apothecary Products, Inc.1984-02-04
LAMINARIA JAPONICA CERVICAL DILATOR (K833068)Medi-Spec1984-02-04
ROAD RUNNER ELECTRIC TREADMILL (K840280)Battle Creek Equipment Co.1984-02-04
DIAGNOSTIC RADIOLOGY CATHETERS (K834459)American Edwards Laboratories1984-02-04
IL HEPARINIZED FLOW DIRECTED THERMAL (K833836)Instrumentation Laboratory CO1984-02-04
MATTRESS COVER, ANTI-MICROBIAL (K832483)American Threshold Industries, Inc.1984-02-04
THROMBOLYTIC ACTIVITY TEST (K834301)Bio/Data Corp.1984-02-04
SILITEK URINARY DIVERSION STENT (K840059)Surgitek1984-02-04
INSPIRON LIQUID OXYGEN SYSTEM (K834290)Inspiron Corp.1984-02-04
EXP* 700 PARALLEL PLATE DIALYZER (K840146)Extracorporeal Medical Specialities, Inc.1984-02-04
T3 RIA (K833853)Syncor Intl. Corp.1984-02-04
BARD KARAYA GUM WASHERS (K834575)C.R. Bard, Inc.1984-02-04
VANISH (K833976)Parke-Davis Co.1984-02-04
INJECTION AIDE UNIT FOR DIAGETICS (K834440)Gottinger Co.1984-02-04
SUR-FIT UROSTOMY POUCH W/ACCUSEAL (K840166)Convatec, A Division of E.R. Squibb & Sons1984-02-04
UROMETER (K833043)Browne Medical, Inc.1984-02-04
HEART CATHETERIZATION TRAY SET (K840022)Medi-Plast Intl., Inc.1984-02-04
PHASE II CORTISOL KIT (K834219)Medical & Scientific Designs, Inc.1984-02-04
PROTOPATH FACTOR IX ASSAY (K834050)American Dade1984-02-04
RENAFLO AVF SET FOR HEMODIALYSIS (K834510)Renal Systems, Inc.1984-02-04
GASTROINTESTINAL SHEATH BRUSH (K834402)Hobbs Medical, Inc.1984-02-04
DRYDEN MINI BACTERIA FILTER (K840205)Dryden Corp.1984-02-04
VERTEX PERCUTANEOUS CATHETER INTRODUC (K840017)Professional Medical Services1984-02-04
ELECATH HEPARIN COATED TEMP. PACING (K840109)Electro-Catheter Corp.1984-02-04
STOPEX-CONDOMS- (K834591)Tropex Worldwide, Inc.1984-02-04
BIOSPAL 2400S (K834579)Hospal Medical Corp.1984-02-04
CARDIOTOMY RESERVORS BCR-3000/3500-Q-120 (K834373)American Bentley1984-02-04
IL 301 PORTABLE TRANSCUT. OXYGEN MONI (K834057)Instrumentation Laboratory CO1984-02-04
DART ALPHA-AMYLASE REAGENT SYSTEM (K834053)Coulter Electronics, Inc.1984-02-04
OPERATING ROOM STAND (K840027)Healthmate, Inc.1984-02-04
EXP* 500 PARALLEL PLATE DIALYZER (K840057)Extracorporeal Medical Specialities, Inc.1984-02-04
FIBRINOGEN TEST (K834571)Diatech, Inc.1984-02-04
ANTENSE ANTI-TENSION DEVICE (K834110)Bio Sig Instruments, Inc.1984-02-04
ADULT INCONTINENCE PAD (K834295)Procter & Gamble Mfg. Co.1984-02-04
ARTERIAL BLOOD GAS INTERPRETATION PROG (K840102)M. D. Software, Inc.1984-02-04
BHCG-CHECK (K834346)Diagnostic Technology, Inc.1984-02-04
C-LOOPS (K833856)Concept, Inc.1984-02-04
SUPERIOR ENTERNAL FEEDING SYSTEM (K833947)Superior Plastic Products Corp.1984-02-04
VISIO-GEM (K833757)Espe GmbH (Us)1984-02-03
WHITE BLOOD CELLS HUMAN TAND B (K833929)Control Diagnostics1984-02-03
ANTACHE ANTI-HEADACHE DEVICE (K834111)Bio Sig Instruments, Inc.1984-02-03
THIOGLYCOLLATE MEDIUM TUBE (K840077)Otisville Biotech, Inc.1984-02-03
TRYPTICASE SOY BROTH TUBE (K840075)Otisville Biotech, Inc.1984-02-03
TANDEM VISUAL HCG IMMUNOENZYMETRIC (K834000)Hybritech, Inc.1984-02-03
LABELED 125I ANTI-IGE (K833419)Allergenetics1984-02-03
RADOVAN SUBCUTANEOUS TISSUE EXPANDER (K833502)American Heyer Schulte1984-02-03
EMIT QST PHENYTOIN ASSAY (K834406)Syva Co.1984-02-03
LUXENE VINYL-JECT 3600-80 (K834046)Howmedica Corp.1984-02-03
MUELLER-HINTON AGAR PLATE (K834421)Otisville Biotech, Inc.1984-02-03
IMMUNO-RA (K834391)Immunostics Co., Inc.1984-02-03
VENTREX PREGNANCY TEST KIT ENZYME (K833960)Vxr, Inc.1984-02-03
SCHEIN COTTON ROLLS, NON-STERILE (K834056)Henry Schein, Inc.1984-02-03
TDX PROCAINAMIDE (K834464)Abbott Laboratories1984-02-03
QUALITATIVE ENZYME IMMUNOASSAY-DETECT (K832905)Btc Diagnostics, Inc.1984-02-03
BLOOD GLUCOSE MONITOR (K834099)Healthdyne, Inc.1984-02-03
IMMUNO-CRP (K834390)Immunostics Co., Inc.1984-02-03
ESCULIN AGAR PLATE (K840073)Otisville Biotech, Inc.1984-02-03
FERTITUBE PREGNANCY TEST #1120 (K832867)Stanbio Laboratory1984-02-03
ALEXOLOK BRACKET (K834272)Alexotek Co.1984-02-03
CONTACT-K APTT REAGENT (K834086)Pacific Hemostasis1984-02-03
MAGNESIUM B TEST (K834075)Wako Chemicals USA, Inc.1984-02-03
DNASE AGAR W/TOLUDINE BLUE PLATE (K840071)Otisville Biotech, Inc.1984-02-03
LIQUI-SERA TDM CALIBRATORS (K834398)Biodiagnostic Intl1984-02-03
EVERTAN SUNTAN BEDS (K834493)Oregon Beauty Supply1984-02-01
GEN. PURPOSE INSTRUMENT TRAYS & (K833058)Inter-Med Corp.1984-01-31
AGC TOTAL KNEE PROSTHESIS (K833921)Biomet, Inc.1984-01-31
SALON -BODY TANNING BED (K834492)Grantan1984-01-31
ANA TRANS TUBE & SWABS STERILE PACK (K834357)Anaerobe Systems1984-01-31
PULSE GENERATOR MODEL 688 (K833519)Burditt & Calkins-Siemens-Elema1984-01-30
COMFEEL PASTE (K833565)Coloplast A/S1984-01-30
BILE ESCULIN AGAR PLATE (K840068)Otisville Biotech, Inc.1984-01-30
EGERTON TURNING & TILTING BED (K834563)Kinetic Concepts, Inc.1984-01-30
PARALLEL FLAME PHOTOMETER & SODIUM (K834248)American Monitor Corp.1984-01-30
CALMTONE (K834519)Thought Technology , Ltd.1984-01-30
CHEMKIT PHENYTOIN DIAG. KIT (K833806)Abbott Laboratories1984-01-30
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