Atlas FDA

1984

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

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RecordFirmDate
AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT (K842113)Mallinckrodt Critical Care1984-07-13
ADVANCED CARDIOVASCULAR-CORONARY GUID (K842195)Advanced Cardiovascular Systems, Inc.1984-07-13
POLYURETHANE THERMAL DILUTION CATHET (K841876)Waters Instruments, Inc.1984-07-13
CENTRAL VENOUS CATHETER W/BIG-GARD (K841828)Norton Performance Plastics Corp.1984-07-13
KERR SEALAPEX ROOT CANAL SEALER (K841910)Sybron Corp.1984-07-13
PENTAD VOCALIZER (K842535)Pentad Corp.1984-07-13
ERIKA NEGATIVE PRESS. ARTERIAL BLOOD (K842436)Erika, Inc.1984-07-13
PERCUTANEOUS CATHETER INTRODUCER SET (K842004)Aries Medical, Inc.1984-07-13
RIGHT ATRIAL CATHETER (K840742)The Healthcare Group Laboratories, Inc.1984-07-13
SHEATH REMOVER (K841878)Datascope Corp.1984-07-13
KIDD VAGINAL SPECULUM (K841867)Paul H. Schneider Ent.1984-07-13
ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232 (K841922)American Edwards Laboratories1984-07-13
WEDGE PRESSURE CATHETER FLOW DIRECTED (K841705)Mansfield Scientific, Inc.1984-07-13
SILVERTORQUE CEREBRAL CATHETER (K840762)Surgimed Corp.1984-07-13
CONVENTIONAL PLASTIC DENTAL TRAYS (K841491)Buffalo Dental Mfg. Co., Inc.1984-07-13
RAAF DUAL LUMEN CATHETER (K842176)Quinton, Inc.1984-07-13
BISFIL-I LIGHT CURABLE POSTERIOR COMPO (K842087)Bisco, Inc.1984-07-12
HAEMATURIA CATHETERS (K841511)Warne Surgical Products, Ltd.1984-07-12
LAKEVILLE BODY VENTILATOR (K840885)Edwards Ventilator Co.1984-07-12
JOHNSON & JOHNSON FLAVORED ETCHING GEL (K842078)Johnson & Johnson Professionals, Inc.1984-07-12
SLIDE PREGNANCY TEST (K842110)Immunostics Co., Inc.1984-07-12
NATURA-DENT VACUUM-FIRED PORCELAIN TEETH (K841826)Parexel Intl. Corp.1984-07-12
GENERATED RETINAL REFLEX IMAGERY SYS (K840840)Electro Optical Instruments1984-07-12
LIFESCAN EEG MONITOR (K841790)Neurometrics1984-07-12
WAKO GLUCOSE C (K842221)Wako Pure Chemical Industries, Ltd.1984-07-12
STRATUS PRIMIDONE FLOROMETRIC ENZY (K842196)American Dade1984-07-11
BETA STICK, PREGNANCY TEST (K841415)Quidel Corp.1984-07-11
RELIABLE (K834479)Reliable Hearing Aide1984-07-11
H-TYPE BRIDGE REMOVER (K842026)Higa Manufacturing , Ltd.1984-07-11
SOFT-TISSUE INSTRUMENT (K841622)Plastafil, Inc.1984-07-11
SHERIDAN/INTENSA TUBE (K842558)Sheridan Catheter Corp.1984-07-11
STREP-A-CHEK (K842600)E-Y Laboratories, Inc.1984-07-11
SLOTTED SOFT-TISSUE INSTRUMENT (K841623)Plastafil, Inc.1984-07-11
IL 1312, PH BLOOD GAS MANAGER (K842042)Instrumentation Laboratory CO1984-07-11
COOK PACEMAKER 216 BIPOLAR CARDIAC - (K841983)Cook Pacemaker Corp.1984-07-11
LEAP LE TEST KIT (K842484)Cooper Biomedical, Inc.1984-07-11
OHIO WASTE GAS SCAVENGING RESERVOIR (K841733)Ohio Medical Products1984-07-11
DRILL GUIDE (K841619)Plastafil, Inc.1984-07-11
COOK PACEMAKER 215 UNIPOLAR CARDIAC- (K841928)Cook Pacemaker Corp.1984-07-11
SPIROLOOP (K841858)Datamed, Inc.1984-07-11
FIAX TRANSFERRIN TEST KIT (K842071)Intl. Diagnostic Technology1984-07-11
BIRD HEATED HUMIDIFIER 3201 (K842523)3M Company1984-07-11
QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT (K841864)Kallestad Laboratories, Inc.1984-07-11
BECTON DICKINSON 1000 INSULIN PUMP (K842685)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-07-10
PLUME FISTULA NEEDLE (K841791)Hospal Medical Corp.1984-07-09
AMER. PHARMASEAL SILICONIZED LATEX (K841544)American Pharmaseal Div. Ahsc1984-07-09
JEJUNOSTOMY SET FOR TUBE FEEDING (K841428)Burron Medical Products, Inc.1984-07-09
OSTOMY FREEDOM KIT (K841173)Ellenberg Assoc.1984-07-09
CYSTO-AID (K841197)E-Z-Em, Inc.1984-07-09
HALO CO LASER SYSTEM (K841234)Directed Energy, Inc.1984-07-09
VARIAN 3300 & 3400 GAS CHROMATOGRAPHS (K841891)Varian Assoc., Inc.1984-07-09
VENTREZYME PHENYTOIN KIT IMMUNOASSAY (K842161)Ventrex Laboratories, Inc.1984-07-09
TRIGLYCERIDES-GPO REAGENT (K842029)Reagents Applications, Inc.1984-07-09
FOREIGN BODY PROTECTOR (K841258)Jayco Pharmaceuticals1984-07-09
SILA CLEAN 20/20 (K832327)Professional Supplies, Inc.1984-07-09
TBG RIA (K842167)Syncor Intl. Corp.1984-07-09
CURITY RIG FOLEY CATH TRAY (K841169)The Kendal Co.1984-07-06
ALL-HANDS TRACHEOSTOMY CARE SET 0101 (K842415)All-Hands Medical Supply, Inc.1984-07-06
DRYDEN INFLATABLE MASK (K842472)Dryden Corp.1984-07-06
TRACHEAL TUBE/STETHOSCOPE (K842464)Mallinckrodt Critical Care1984-07-06
CANNU-SKREEN-PRELIMINARY (K841831)Biochemical Diagnostic, Inc.1984-07-06
DACOMED RIGISCAN SYSTEM (K841202)Dacomed Corp.1984-07-06
MAXICAMERA 400 AC (K841906)General Electric Co.1984-07-06
SAMSON'S NEWBORN LUNG INFLATOR 340-1000 (K842487)J. H. Emerson Co.1984-07-06
ULTRA CHEM ENZYMATIC TRIGLYCERIDE (K842211)Em Diagnostic Systems, Inc.1984-07-06
HOSPAL BIOSPAL SCU/CAVH KIT (K841152)Hospal Medical Corp.1984-07-06
COOK PACEMAKER CORP. 115 UNIPOLAR CARDI (K842081)Cook Pacemaker Corp.1984-07-06
DISPO. AES DISPOS. SYRINGE W/NEEDLE (K841931)Hirsch Chemie , Ltd.1984-07-06
UMI CURVED CHEMONUCLEOLYSIS NEEDLE (K842012)Universal Medical Instrument Corp.1984-07-06
CLINICAL ELECTRONIC THERMOMETER (K841780)Fidelity Medical, Inc.1984-07-06
MULTIVARIATE DIGITAL CARDIOGRAPH (K840875)Clinical Microsystems Intl.1984-07-06
AMER. MEDICAL PLASTICS CO 20100 (K842492)American Medical Plastics Co.1984-07-06
STERILE HICHMAN/BROVIAC INJECTION CAP (K840846)Evermed, Inc.1984-07-06
STERILE PAN SET (K842136)Medi-Plast Intl., Inc.1984-07-06
RECTAL IRRIGATION TUBE (K841289)Hdc Corp.1984-07-06
HEMO-RO WATER PURIFICATION SYS (K841403)Millipore Corp.1984-07-06
LIEBEL-FLARSHEIM ACS 1000 CHEST X-RAY (K841756)Syvron Corp.1984-07-06
JET VENTILATION ADAPTOR (K842456)Portex, Inc.1984-07-06
SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY (K842134)Somas Medical Industries, Inc.1984-07-06
SAWYER FIRST AID KIT (K842015)Saffeta, Inc.1984-07-06
BP TRAUMA AIR PANTS (K841605)Bp Medical Systems, Inc.1984-07-06
RADIOGRAPHIC FILM PROCESSOR M-30CR & (K841431)The Allen Products Co.1984-07-06
SCANLAN ATRAUM INSTRUMENT JAW COVER (K841513)Scanlan Intl., Inc.1984-07-06
MARK5 ARTERIAL BLOOD GAS KIT (K841810)Martell Medical Products, Inc.1984-07-06
SENTECH'S ULAB 1000 CLINICAL CHEM. (K841575)Sen Tech Medical Corp.1984-07-06
CAUSSE SPONGE BOAT (K841353)Treace Medical, Inc.1984-07-06
KODAK EKTACHEM CONTROL (K841884)Eastman Kodak Company1984-07-06
CURETTE (K841354)Treace Medical, Inc.1984-07-06
RENATRON (K842258)Renal Systems, Inc.1984-07-06
BEHRING ELISA PROCESSOR M (K841043)Behring Diagnostics, Inc.1984-07-06
NON-CORING NEEDLE (K841742)Creative Care Systems, Inc.1984-07-06
HI-LO FLOOR STANDING EXAM. LIGHT (K842135)Good-Lite Co.1984-07-06
PULSE GENERATOR 678L (K841233)Siemens Elema AB1984-07-06
HEPARIN CAP, INJECTION CAP MALE LUER- (K841772)Linton Biomed Corp.1984-07-06
SAMSON 1000 ANESTHESIA CIRCUIT (K842488)J. H. Emerson Co.1984-07-06
BACTIGEN - N.MENNINIGITIDIS TEST (K841907)Armkel, LLC1984-07-06
RIGHT ANGLED PICK (K841355)Treace Medical, Inc.1984-07-03
TISCHLER CERVICAL BIOPSY PUNCH FORCEPS (K842112)J. Sklar Mfg. Co., Inc.1984-07-03
SURE & NATURAL MAXI-SHIELD (K842480)Johnson & Johnson Professionals, Inc.1984-07-03
EPIDURAL TRAYS (K842095)Concord Laboratories, Inc.1984-07-03
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