Atlas FDA

1984

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

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RecordFirmDate
INFANT WARMER (K833802)Kinetic Concepts, Inc.1984-04-05
LEVINE EOSIN METHYLENE BLUE AGAR (K841142)Anaerobe Systems1984-04-05
HARVARD ANTI-REFLUX Y-SET (K840760)C.R. Bard, Inc.1984-04-05
FLOW-PAC CPK REAGENT SET (K832977)American Research Products Co.1984-04-05
USCI ENDOPROSTHESIS (K834574)C.R. Bard, Inc.1984-04-05
RISTOCETIN COFACTOR ASSAY (K840329)Helena Laboratories1984-04-05
PROPAGATING TRANSPORT (K841208)Smith River Biologicals1984-04-05
PREFILLED PULSATOR SYRINGE (K840986)Concord Laboratories, Inc.1984-04-05
PROVIDER CAP SET (K841028)Pancretec, Inc.1984-04-05
SELECTIVE BROTH (K841211)Smith River Biologicals1984-04-05
ALEXOTEK LINGUAL TUBES (K834446)Alexotek Co.1984-04-05
CLICK-COUNT U100 INSULIN SYRINGE (K833706)Orange Medical Instruments, Inc.1984-04-05
MAX-I-PROBE PERIODONTAL ENDODONTIC PROB (K840237)Smith & Nephew, Mpl Division1984-04-05
DIRECT BILIRUBIN REAGENT (K840777)American Dade1984-04-05
VAPORIZED HEPARIN (K840987)Concord Laboratories, Inc.1984-04-05
PARAMAX UREA NITROGEN REAGENT (K840785)American Dade1984-04-05
HYPODERMIC NEEDLES & STYLETS (K840033)Microvasive1984-04-05
CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR (K841218)Anaerobe Systems1984-04-05
ENGSTROM ELIZA DUO CO2 & O2 ANALYZ (K840645)Gambro, Inc.1984-04-05
CIN-SHEAR (K840352)Roland J. Zwick, Inc.1984-04-05
CYSTOTOME, 140-S (K840475)Cilco, Inc.1984-04-05
SOMAS HUMAN SPINAL FLUID CONTROL (K840974)Somas Medical Industries, Inc.1984-04-05
CAT. 8 DENTAL DEVICES (K840312)Imm Enterprises , Ltd.1984-04-05
ONE-WAY AIR VALVE (K840253)Delta Medical Industries1984-04-05
ANA APPLELISA (K834241)Apple Diagnostic Products1984-04-04
LIQUI-URA CHEMISTRY URINE CONTROLS (K840618)Biodiagnostic Intl1984-04-04
EPILOT 80 S TM (K833946)Leo Unlimited, Inc.1984-04-04
ANTIMICROBIAL SUSCEPT-CULTURE MEDIA (K841213)Smith River Biologicals1984-04-04
CARBON DIOXIDE CALIBRATOR I (K840774)American Dade1984-04-04
SENSIBEAD EIA IGE KIT (K840674)Terumo Medical Corp.1984-04-04
DETECT GROUP A STREP TEST (K834582)Difco Laboratories, Inc.1984-04-04
PARAMAX CHOLESTEROL REAGENT (K840776)American Dade1984-04-04
ASPARTATE AMINOTRANSFERASE REAGENT (K840706)American Dade1984-04-04
CATS-CLINICAL LAB COMPUTER SOFTWARE- (K840502)Precision Technology, Inc.1984-04-04
PROGRESS SELECTIVE DHEMISTRY ANALYZ (K840200)Kone Instruments, Inc.1984-04-04
SELECTIVE & NON-DIFFERENTIAL (K841210)Smith River Biologicals1984-04-04
IMMPULSE TOBRAMYCIN ASSAY REAGENTS (K840847)Paragon Diagnostics, Inc.1984-04-04
SWABZYME-OXIDASE (K840810)E-Y Laboratories, Inc.1984-04-04
BAKTERIETTE-VI-PAK (K840719)Great Lakes Intl.1984-04-04
MANUAL BLOOD CELL COUNTING DEVICE (K841026)Instrumentation Laboratory CO1984-04-04
GENERAL NUTRIENT BROTH (K841203)Smith River Biologicals1984-04-04
GASPAK PLUS DISPOS. HYDROGEN & (K841117)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-04-04
CARBON DIOXIDE CALIBRATOR II (K840775)American Dade1984-04-04
ENTERNAL Y EXTENSION SET RECORDER (K840656)Corpak Medsystems1984-04-04
SERATEST RF LATEX DETERMINATION (K840863)Seragen Diagnostics, Inc.1984-04-04
BANGORT LIFESTYLE COLOSTOMY POUCHES (K841029)Howmedica Corp.1984-04-04
QUINIDINE ANALYTICAL TEST PACK (K840596)E.I. Dupont DE Nemours & Co., Inc.1984-04-04
SINGLE BIOCHEMICAL TEST (K841212)Smith River Biologicals1984-04-04
PDC HDL EZ-SEP CHOLESTEROL REAGENT (K840676)Preventive Diagnostics Corp.1984-04-04
ANAEROBIC TRANSPORT MEDIUM (K841220)Anaerobe Systems1984-04-04
PARAMAX AMMONIA REAGENTT (K840770)American Dade1984-04-04
SDI SURGICAL DRAPE (K833176)Sdi1984-04-04
VENTREZYME T4 IMMUNOASSAY T4 (K840473)Vxr, Inc.1984-04-04
BOVIE CONDUCTIVE ADHES-DISPER-ELECTRO (K834048)Castle Co.1984-04-04
SICKLE HB ASSAY (K841170)Isolab, Inc.1984-04-04
IMMPULSE THEOPHYLLINE ASSAY REAGENTS (K840758)Paragon Diagnostics, Inc.1984-04-04
ENDOTOME PNEUMATIC ORTHOPAEDIC CUT (K840831)Cabot Medical Corp.1984-04-04
AMERLEX HUMAN PLACENTAL LACTOGEN (K840588)Amersham Corp.1984-04-04
BRAIN HEART INFUSION BROTH (K841221)Anaerobe Systems1984-04-04
MUELLER HINTON AGAR W/BLOOD & COFACTOR (K841138)Anaerobe Systems1984-04-04
OLSEN 756 ROCKER SWITCHPEN (K834329)Olsen Electro-Surgical Instruments, Inc.1984-04-04
TTI REHABILATATION GYM SYS (K841112)Therapeutic Technologies, Inc.1984-04-04
NON PROPAGATING TRANSPORT (K841205)Smith River Biologicals1984-04-04
SHOPPED MEAT CARBOHYDRATE (K841219)Anaerobe Systems1984-04-04
HAEMOPHILUS INFLUENZAE TYPE B (K840506)Scientific Device Laboratory, Inc.1984-04-04
DIETO CONTAINER FOR ENTERNAL NUTRIT (K840916)Gil-Med Industries C/O Kegan & Kegan, Ltd.1984-04-04
B-NEOCEPT 30 (K840650)Organon, Inc.1984-04-04
ADRENOCORTICOTROPIC HORMONE TEST (K833934)Clinetics Corp.1984-04-04
BACTEROIDES BILE ESCULIN GAR (K841222)Anaerobe Systems1984-04-04
REAGENTS & STANDARDS IL 501 NA/K (K840557)Shaban Mfg. Co.1984-04-04
PHILLY INFANT BOLT (K840999)Philadelphia Medical Specialties1984-04-04
PARAMAX ACID PHOSPHATASE REAGENT (K840661)American Dade1984-04-04
CARBON DIOXIDE REAGENT (K840773)American Dade1984-04-04
PALL HEAT MOISTURE EXCHANGING FILTER (K834292)Pall Biomedical Products Co.1984-04-04
ACCULAB SUPPLIES CHEMICAL ANALYZERS (K840501)Precision Technology, Inc.1984-04-04
S-CAL HEMATOLOGY CALIBRATOR (K840794)Coulter Electronics, Inc.1984-04-04
EKTACHEM CLINICAL CHEM. SLIDES (K840606)Eastman Kodak Company1984-04-04
OP-CON SURG. INSTRUMENT #3 (K834171)Imm Enterprises , Ltd.1984-04-04
MAST INHALANT PROFILE (K834526)Mast Immunosystems1984-04-04
DOUBLE-COAGULATION SWITCHPEN 757 (K834410)Olsen Electro-Surgical Instruments, Inc.1984-04-04
PARATHYROID HORMONE ANALYSIS PRODUCT (K840379)Nichols Institute Diagnostics1984-04-04
INJECTION CAP OR ADAPTOR (K841405)Medcare Disp Products, Inc.1984-04-04
CREATINE KINASE MB REAGENT (K840783)American Dade1984-04-04
MID-STREAM URINE COLLECTION SETS (K840709)Concord Laboratories, Inc.1984-04-03
ONE-PIECE SHUNT (K834593)American Heyer Schulte1984-04-03
CANAL AID (K840165)Qualitone1984-04-03
MC 2000 OSTOMY POUCHES (K840269)Coloplast A/S1984-04-02
FILTRODER FILTERS (K840267)Coloplast A/S1984-04-02
BIOSPAL 2400S (K840812)Hospal Medical Corp.1984-04-02
PULMONARY FUNCTION SYS-3000 (K840711)Med-Science Electronics, Inc.1984-04-02
BIOSPAL 3000S (K840811)Hospal Medical Corp.1984-04-02
MEDICAL LASER ENDOCOAGULATOR 5K (K840854)Hgm, Inc.1984-04-02
RAST ALLERGO SORBENT TEST (K840537)Pharmacia, Inc.1984-04-02
SURGITEK ALL SILICONE INFECTION DOUBJ (K833782)Surgitek1984-04-02
HOSPAL MODEL H1210 (K840814)Hospal Medical Corp.1984-04-02
MULTIPLE (K833259)Sun House Products Co.1984-04-02
BIOSPAL 1200S (K840813)Hospal Medical Corp.1984-04-02
FIBERLAS 100 MEDICAL SYSTEM (K833499)Fiberlase U.S.A.1984-04-02
AMIKACIN REAGENT TEST KIT (K840647)Beckman Instruments, Inc.1984-04-02
FLEXI-FLATE PENILE IMPLANT (K834347)Surgitek1984-04-02
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