Atlas FDA

1984

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

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RecordFirmDate
OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT (K841031)American Bentley1984-05-23
THERMODILUTION CATHETER (K840992)Gould, Inc.1984-05-23
OASIS CLUB HYDROMASSAGE (K841954)Prexcor America, Inc.1984-05-23
ALPHA PLUS 1 (K841921)Alpha Unlimited, Inc.1984-05-23
TEC-3500 DEFIBRILLATOR (K840258)Nihon Kohden America, Inc.1984-05-23
ALPHA 4 X 4 (K841912)Alpha Unlimited, Inc.1984-05-23
PATIENT TUBING HYTREL SIEMENS-ELEMA (K841657)Siemens Elema AB1984-05-23
MAC-MULTI-ADJUSTABLE CHAIR (K841920)Alpha Unlimited, Inc.1984-05-23
TRIPLE LUMEN INFUSION CATHETER/ACCESS (K841535)Gish Biomedical, Inc.1984-05-23
SIEMENS-ELEMA VENTILATOR 900C (K841529)Siemens Elema AB1984-05-23
IMPLANTABLE ELECTRODE UNIPOLAR ADAPT (K840026)Telectronics, Inc.1984-05-23
EZY-RAMP (K841994)Ezy-Ramp Co.1984-05-23
HEPARIN COATED THERMODILUTION CATHETERS (K840824)Gould, Inc.1984-05-23
ALPHA TRI-KART (K841919)Alpha Unlimited, Inc.1984-05-23
ARTERIAL BLOOD SAMPLING KITS (K841486)Concord Laboratories, Inc.1984-05-23
EMERGENCY INFUSION DEVICE (K840455)Arrow Intl., Inc.1984-05-23
BEAR 33 (K841279)Bear Medical Systems, Inc.1984-05-23
ALPHA PUSH KART (K841911)Alpha Unlimited, Inc.1984-05-23
INNOFLUOR PHENOBARBITAL (K841707)Innotron Diagnostics1984-05-23
ANGIOSCANE SPECTRUM ANALYZER (K834501)Unigon Industries, Inc.1984-05-23
CIRCULATOR MINIBOOT (K833627)Circulator Boot Corp.1984-05-23
ANGIOSCAN FLO MAD SPECTRUM ANALYZER (K834525)Unigon Industries, Inc.1984-05-23
BIOMER * PLEDGET SUTURE BUTTRESS (K832138)ETHICON, Inc.1984-05-23
HUCKSTEPS STAPLES (K841125)Downs Surgical , Ltd.1984-05-23
WALDMANN SUNTANNING EQUIP-MODELS'S (K840555)Eurotan Intl.1984-05-23
D.L. SCOPE BLADE & HANDLE (K841778)North American Medical Products, Inc.1984-05-23
IMPLANTABLE ELECTRODE BIPOLAR ADAPT (K840025)Telectronics, Inc.1984-05-23
OHIO WASTE GAS SCAVENGING INTERFACE (K842003)Ohio Medical Products1984-05-23
C-19 (K841269)Pentron Corp.1984-05-22
BLOOD SPOT NEONATAL TSH RADIOIMMUNO (K841606)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-05-22
PHACOEMULSIFICATION KITS (K840695)Innovative Surgical Products, Inc.1984-05-22
CONCENTRATE CONDUCTIVITY METER (K841543)Renal Systems, Inc.1984-05-22
NUMBER 21 R/R SYSTEM (K841457)Pentron Corp.1984-05-22
CENTAURI CT SCANNER (K840860)Technicare Corp.1984-05-22
TAGO DIFFU-GEN C-REACTIVE PROTEIN (K841265)Tago, Inc.1984-05-22
INNOFLUOR PHENYTOIN (K841706)Innotron Diagnostics1984-05-22
NUMBER 20 R/L SYSTEM (K841458)Pentron Corp.1984-05-22
SIGMA PROCEDURE 16-UV (K841555)Sigma Chemical Co.1984-05-22
DILATION BALLOON CATHETER (K834413)Hobbs Medical, Inc.1984-05-22
C-17 (K841268)Pentron Corp.1984-05-22
TERUMO SENSIBEAD THYROXINE EIA KIT (K841601)Terumo Medical Corp.1984-05-22
I/A PROBE LINES (K834577)Frigitronics of Connecticut, Inc.1984-05-22
GASTROSTOMY FEEDING TUBE (K841330)Microvasive1984-05-22
SCOTTS TAP WATER SUBSTITUTE 7 (K841423)Reagent Laboratory, Inc.1984-05-22
ORTHO MICROWELL READER (K841557)Ortho Diagnostic Systems, Inc.1984-05-22
CODE-A-WELL SERIES 300 PLATE (K841937)Plastic Injectors, Inc.1984-05-22
MAKS CENTRAL DELIVERY SYS-11-200 ETC (K840859)Erika, Inc.1984-05-22
DUPONT THEOPHYLLINE ASSAY KIT (K841656)E.I. Dupont DE Nemours & Co., Inc.1984-05-22
STORZ UNIVERSAL EYE SHIELD (K841599)Storz Instrument Co.1984-05-22
TECHNICON RA-1000 SYS T4-THYROXINE (K841576)Technicon Instruments Corp.1984-05-22
WUNDERFIL (K841667)Harry J. Bosworth Co.1984-05-22
ELECTRO-PALATE (K840892)Cisko Systems1984-05-22
SUNGLASSES (K841794)Whole Sale Importers1984-05-22
AMRESCO E4A REAGENT SET (K840868)American Research Products Co.1984-05-22
EXTRACTABLE NUCLEAR ANTIGEN ASSAY (K840221)Zeus Scientific, Inc.1984-05-22
LINEAR CLOUD TONOMETER (K841089)Linear Tonometers, Inc.1984-05-22
DISPOSABLE SCLERAL GLOBE PLUG (K840693)Innovative Surgical Products, Inc.1984-05-22
KODAK EKTACHEM DT 60 ANALYZER (K841503)Eastman Kodak Company1984-05-22
SUN-LITE WHITE SPOT (K841588)Suncoast Medical Manufacturers, Inc.1984-05-22
ACCURATE BETA 30 PREGNANCY TEST KIT (K841602)Organon, Inc.1984-05-22
C-LITE (K841589)Suncoast Medical Manufacturers, Inc.1984-05-22
DISPOSABLE POLY GLOVES (K841676)Abco Dealers, Inc.1984-05-22
ALBINAR ELECTRONIC DIGITAL THERMOMETER (K841260)Dimension Specialty Co., Inc.1984-05-21
PLASTIC, STERILE TUBING CLOSED SET (K841185)Marbex, Inc.1984-05-21
CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- (K833447)Bartels Immunodiagnostic Supplies, Inc.1984-05-21
SODIUM CHLORIDE SOLUTION BLOOD CELL (K841183)Reagent Laboratory, Inc.1984-05-21
SYRINGE ADDITIVE IV ADMIN. SETS (K841361)Quest Medical, Inc.1984-05-21
INFUSION SET SCALP VEIN (K841186)Marbex, Inc.1984-05-21
GRAMS ASPIRATOR S-300 (K840803)Grams Medical, Inc.1984-05-21
TYCOS SELF CHECK BPM3 BLOOD PRESS MONI (K840469)Sybron Corp.1984-05-21
SOLOPAK BRAND FILTER NEEDLE W/5 MICRO (K841280)Smith & Nephew, Mpl Division1984-05-21
RUBELLA IGG ANTIBODY ELISA TEST SYS (K841200)Ortho Diagnostic Systems, Inc.1984-05-21
HAEMOPHILUS ISOLATION AGAR 2827 (K841673)Gibco Laboratories Life Technologies, Inc.1984-05-21
KERR RESIN BONDED BRIDGE CEMENT (K840407)Sybron Corp.1984-05-21
AB MANUAL VENTILATION ACCESS. 900C (K841393)Siemens Elema AB1984-05-21
ETHOX RELIA-FLO 2001 ENTERAL FEED (K841512)Ethox Corp.1984-05-21
JOHNSON & JOHNSON POSTERIOR DENTAL (ADAPTIC II) (K841518)Johnson & Johnson Professionals, Inc.1984-05-21
WINDSOR MEDICAL MODEL 50-00002 (K841481)Windsor Medical, Inc.1984-05-21
VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN (K840830)Ventrex Laboratories, Inc.1984-05-21
VENTREXYME EIA CONTROLS IMMUNOASSAY (K841456)Vxr, Inc.1984-05-21
ENRICHED CULTURE MED. TRYPTIC SOY AGAR (K841838)Microline Scientific1984-05-21
BLOOD PRESSURE MONITOR BP600X (K834441)Lifeline Systems, Inc.1984-05-21
ENRICHED CULTURE MED. FLUID THIOGLYC0 (K841837)Microline Scientific1984-05-21
PHADEXACT SERUM, TOTAL IGE CONTROLS (K840476)Pharmacia, Inc.1984-05-21
CAPILLARY GAS CHROMATOGRAPHIC COLUMNS (K841712)Supelco, Inc.1984-05-21
EAR KNIVES (K840764)Sharpoint, Inc.1984-05-21
TOXO-G EIA DIAGNOSTIC KIT (K840879)Abbott Laboratories1984-05-21
CONTACT LENS CASE FOR RIGID GAS PERMA (K840691)Optimum Manufacturers, Inc.1984-05-18
BURN BATH (K841397)Setma, Inc.1984-05-18
YAG LASER 8000 - LOWER GI APPLICAT (K840142)Cooper Lasersonics, Inc.1984-05-18
YAG LASER 8000 GASTROINTESTINAL BLEE (K840144)Cooper Medical Corp.1984-05-18
SODIUM ELECTRODE RINSE SOLUTION 2 (K841418)Reagent Laboratory, Inc.1984-05-16
FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000 (K841087)Machida America, Inc.1984-05-16
STROLLER SPRINT (K841808)Cryogenic Assoc.1984-05-16
OEC/REZAIAN SPINAL FIXATOR (K841189)Orthopedic Equipment Co., Inc.1984-05-16
RICHARDS FIXATOR SYSTEM (K841334)Richards Medical Co., Inc.1984-05-16
FLATPACK CARRYING CASE (K841316)Bausch & Lomb, Inc.1984-05-16
CARDIAC PULSE GENERATOR 254-18 (K841074)Intermedics, Inc.1984-05-16
CORNING LACTATE DEHYDROPHORETIC ASSAY (K841433)Corning Medical & Scientific1984-05-16
HYPERBARIC OXYGEN GURNEY- (K841368)Orthopedic Systems, Inc.1984-05-16
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