Atlas FDA

1981

3,287 FDA 510(k) clearances · Clearance year

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RecordFirmDate
EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI (K811262)Zeus Scientific, Inc.1981-05-27
NOVA 5 (K811289)Nova Biomedical Corp.1981-05-27
NITROGLYCERINE IV SET (K810317)Abbott Laboratories1981-05-27
DENTMED V-PACKS (K810801)Univ. of Bristol Dental School1981-05-27
OMNI (K811158)Omni Hearing Systems1981-05-27
SIRECUST 358 (K803208)Siemens Corp.1981-05-27
BYPASS COIL (K811068)G.D. Searle and Co.1981-05-27
ASSURE NATURAL FIT TAMPON (K811214)Personal Products Co.1981-05-21
CITRATE BUFFER (K811251)Bioscientific1981-05-21
SAF SINGLE-USE AEROSOL FILTER (K811203)Sorensen Research1981-05-21
MALE LUER LOCK PLUGS (K810921)Procedure Products, Inc.1981-05-21
DIGOXIN (RIA) KIT (K811212)Immuno Assay Corp.1981-05-21
MARZ-175 (K811199)Emde Corp.1981-05-21
DISPOSABLE UNDERPADS (K811232)Burina1981-05-21
FOCUS STERILE SYRINGES (K811167)Stanford Laboratories1981-05-21
ROLL-A-SET (K810918)Principle Business Ent.1981-05-21
MOLDED POLYSULFONE TRIAL PROSTHESIS (K811205)Shannon Group1981-05-21
DISPOSABLE STERILIZATION WRAP (K811242)Amsco Co.1981-05-21
BRONCHEK-SHILEY CARDIAC JACKET & BSC J (K811204)Shiley, Inc.1981-05-21
SYSTEM 400 (K810973)Philips Medical Systems (Cleveland), Inc.1981-05-21
INORGANIC PHOSPHORUS REAGENTS (K811222)Connecticut Diagnostics, Ltd.1981-05-21
SELF HEATING DISPOSABLE HEAT PAD (K811206)Ensar Corp.1981-05-21
TECHNICON SMAC II SYSTEM & ACCESSORIES (K811249)Technicon Instruments Corp.1981-05-21
FLUID WARMER (K803249)Datachem, Inc.1981-05-21
PREFILLED PULSATOR SYRINGE (K810995)Concord Laboratories, Inc.1981-05-21
KOVA STRIP 6 (K811219)Icl Scientific1981-05-21
VASOVASOSTOMY STABILIZER PLATFORM DEV (K811223)Biomet, Inc.1981-05-21
BETA I & BETA II (K811082)Porta Ray, Inc.1981-05-21
EFTEKHAR ACETABULAR STANDOFF (K811201)Zimmer, Inc.1981-05-21
MODEL 1100 SPHYGMOMANOMETER (K811208)Y1981-05-21
SUR-FIT DISPOSABLE FANGE CAP (K811163)E. R. Squibb & Sons, Inc.1981-05-21
SPENCO DERMAL PADS (K811184)Spenco Medical Corp.1981-05-20
SC/TEMP 300 (K810332)Thought Technology , Ltd.1981-05-18
APC IMPLANTABEL PACING LEAD, MODEL 3264 (K810399)American Pacemaker Corp.1981-05-15
HUMAN IGG-ALBUMIN TEST KIT (K811178)Meloy Laboratories, Inc.1981-05-15
NORELCO BLOOD PRESSURE METER (K811188)North American Philips Corp.1981-05-15
GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I (K810043)Vibac Corp.1981-05-15
ANIS IRRIGATING SPATULA (K810937)American V. Mueller1981-05-15
APC IMPLANTABLE PACING LEAD-FLANGE #3260 (K810397)American Pacemaker Corp.1981-05-15
ARIA II INSULIN RIA (K811144)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-05-15
MULTIANALYTE CONTROLS, ALL KINDS (K811182)Fisher Scientific Co., LLC1981-05-15
TIGGES SPINAL (K811176)The Tiggs Co.1981-05-15
COLLARLESS TOTAL HIP FEMORAL COMP. SYS (K811151)Howmedica Corp.1981-05-15
OSMOMETER MODEL OM-6010 (K811179)Fiske Med Science1981-05-15
PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT (K811169)Amersham Corp.1981-05-15
APC IMPLANTABLE PACING LEAD, MODEL 3266 (K810398)American Pacemaker Corp.1981-05-15
URINE PREGNANCY TEST STANDARD/CONTR. PK (K811150)Mallinckrodt Critical Care1981-05-15
APC IMPLANTABLE PACING LEAD, TINED #3262 (K810396)American Pacemaker Corp.1981-05-15
ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ (K811180)American Optical Corp.1981-05-15
POSITIVE CLOSURE ANESTHETIC VALVE (K811015)Orthopedic Systems, Inc.1981-05-15
HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE (K811011)Sigma Chemical Co.1981-05-15
QUANTA PHASE VITAMIN B-12/FOLATE RAD (K811177)Bio-Rad1981-05-15
CORATOMIC MODEL OVALITH-920 (K810808)Coratomic, Inc.1981-05-15
MODELS 8420 THRU 8423 PACEMAKER GENER (K810734)Medtronic Vascular1981-05-15
DADE RPR CARD TEST (K811152)American Dade1981-05-15
FOGARTY FLEXIBLE CALIBRATOR (K810894)American Edwards Laboratories1981-05-15
GAMMA CAMERA (K810974)Siemens Gammasonics, Inc.1981-05-13
BASAL MEDIUM EAGLE W/HANKS' SALTS (K810773)Dutchland Laboratories, Inc.1981-05-13
HCG RADIOIMMUNOASSAY (K811116)Hoffmann-La Roche, Inc.1981-05-13
ALSEVER'S SOLUTION (MODIFIED) (K810783)Dutchland Laboratories, Inc.1981-05-13
DISPOSABLE HOLDER FOR HANCOCK MITRAL (K811235)Vascor, Inc.1981-05-13
PH/BLOOD GAS CONTROL (ABC) (K811143)Instrumentation Laboratory CO1981-05-13
MINIMUM ESSENTIAL MEDIUM EAGLE W/EARLE (K810769)Dutchland Laboratories, Inc.1981-05-13
PHADEBAS ISOAMYLASE TEST (K810584)Pharmacia, Inc.1981-05-13
DAHLBERG MODEL AM (K811226)Dahlberg Electronics, Inc.1981-05-13
EARLE'S BALANCED SALTS SOULTION (K810779)Dutchland Laboratories, Inc.1981-05-13
L-GLUTAMINE (K810781)Dutchland Laboratories, Inc.1981-05-13
WATER-TISSUE CULTURE GRADE (K810774)Dutchland Laboratories, Inc.1981-05-13
BASAL MEDIUM EAGLE (MOD.) W/EARLE'S SALT (K810778)Dutchland Laboratories, Inc.1981-05-13
HEARING AID, UNITRON MODEL C5-H (K811174)Unitron Industries, Inc.1981-05-13
MODEL FBS-1, FLEXIBLE BRONCHOSCOPE (K811181)American Optical Corp.1981-05-13
DISPOSABLE HOLDER FOR HANCOCK AORTIC (K811236)Vascor, Inc.1981-05-13
XIMATRON V (K810858)Siemens Corp.1981-05-13
ESOPHAGEAL PILL ELECTRODE (K810895)Con Med Equipment, Inc.1981-05-13
MED. 199(MODIFIED) W/HANKS' SALTS (K810770)Dutchland Laboratories, Inc.1981-05-13
HOYT ECONO-TRAY (K811154)Hoyt Laboratories1981-05-13
ENDODONTIC POST SYSTEMS (K810977)Preat Corp.1981-05-13
MINIMUM ESSENTIAL MEDIUM EAGLE W/HANKS (K810768)Dutchland Laboratories, Inc.1981-05-13
KEELER/KONAN SPECULAR MICROSCOPE (K810403)Keeler Optical Products , Ltd.1981-05-13
PENICILLIN-STREPTOMYCIN MIXTURE (K810776)Dutchland Laboratories, Inc.1981-05-13
K-MED ENCOURAGER INCENTIVE SPIROMETER (K810641)K-Med, Inc.1981-05-13
TRYPAN BLUE (0.5% IN NORMAL SALINE) (K810782)Dutchland Laboratories, Inc.1981-05-13
MEDIUM 199 W/EARLE'S SALTS & GLUTAMINE (K810772)Dutchland Laboratories, Inc.1981-05-13
L-15 MEDIUM (MODIFIED) (K810771)Dutchland Laboratories, Inc.1981-05-13
SODIUM BICARBONATE (7.5%) SOLUTION (K810780)Dutchland Laboratories, Inc.1981-05-13
ARALUEN HEAD SHIELD (K810868)Araluen, Inc.1981-05-13
SHILEY LOW PRESSURE THIN-CUFFED TRACH (K811033)Shiley, Inc.1981-05-13
BALANCE ARTICULATOR (K811075)Almore Intl., Inc.1981-05-13
ELECTRODYN CII-INTERFERENTIAL MUSCLE (K810513)Nemectron Medical, Inc.1981-05-11
INSTRUMENT CLEANER LIQUID CONCENTRATE (K803154)Abco Dealers, Inc.1981-05-11
SCANEL 100 (K810945)Cgr Medical Corp.1981-05-08
RPMI 1640 MEDIUM (K810767)Dutchland Laboratories, Inc.1981-05-08
FLOWLOCK OXYGEN METER (K811162)Lifeguard Medical Products, Inc.1981-05-08
HOME HEALTH CHEKUP KIT (K810488)Healthkit1981-05-08
AIM SYSTEM (FOR IGG) (K811126)Icl Scientific1981-05-08
AIM SYSTEM (FOR IGM) (K811124)Icl Scientific1981-05-08
EPILATRON (K810843)Electrola1981-05-08
AUTOMATIC ELISA READER (K811111)Artek Systems Corp.1981-05-08
5CM SMALL PARTS SCANNER (K810914)Smithkline Diagnostics, Inc.1981-05-08
LUTEINIZING HORMONE DIRECT RIA KIT 125/I (K811024)Immunalysis Corporation1981-05-08
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