Atlas FDA

1980

2,857 FDA 510(k) clearances · Clearance year

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RecordFirmDate
WHOLE BLOOD PLATELET CONTROL NORMAL, (K792606)Dade, Baxter Travenol Diagnostics, Inc.1980-02-13
BOVINE ALBUMIN 22% & 30% SOLUTIONS (K800189)Gotham Biologics, Inc.1980-02-13
ACCUSTROKE PIPET (K800141)Beckman Instruments, Inc.1980-02-13
CENTRIFICHEM URIC ACID (K800130)Union Carbide Corp.1980-02-13
STANBIO DIRECT URIC ACID TEST SET #0770 (K800190)Stanbio Laboratory1980-02-13
DURAZYME GPT/ALT (K800115)American Monitor Corp.1980-02-13
CULTURIA MACCONKEY/CLED #DM87 (K800215)Clinical Convenience Products, Inc.1980-02-13
AZIDE BLOOD AGAR BASE W/&WTHOT SHP. BLD (K800158)Isle Media and Sterile Products, Inc.1980-02-13
CENTRIFICHEM BUN (K800128)Union Carbide Corp.1980-02-13
CALBIOCHEM-BEHRING RIA-COUNT (K792460)Calbiochem-Behring Corp.1980-02-13
DURAZYME GOT/AST (K800116)American Monitor Corp.1980-02-13
MICROMEDIC PUNCH & ELUTER (K800075)Micromedic Systems1980-02-13
TS-301 THREE-WAY PULP TESTER (K800138)Tamler-Stoneham Instruments1980-02-13
AMES RIALYZE - CHROMATOGRAPHY TUBES (K800169)Miles Laboratories, Inc.1980-02-13
EMC-M-175, THYROXINE - 100 TUBES (K800187)Endocrine-Metabolic Center1980-02-13
AMES RIALYZE - UPTAKE CHROM. TUBES (K800170)Miles Laboratories, Inc.1980-02-13
DEXTEX II STERILIZATION WRAP (K800123)Ahlstrom Dexter1980-02-13
COTTON UNDER CAST PADDING (K800195)Winn Hirsch & Assoc.1980-02-11
COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE (K792669)Ge Medical Systems Information Technologies1980-02-11
COMBISON 100-MODEL 100 & 110 (K800091)Kt Medical, Inc.1980-02-11
AMP DIRECT VASCULAR MONITORING SYSTEM (K792646)American Medical Products, Inc.1980-02-11
ONCE TM (K800162)G.D. Searle and Co.1980-02-11
TRU-PULSE PADS (K800117)Ipco Corp.1980-02-11
CENTRIFICHEM ALP/ALKALINE PHOSPHATASE (K800131)Union Carbide Corp.1980-02-11
MODEL 807 SUCTION CAUTERY FINGER TIP (K800022)Malibu Laboratories1980-02-11
MINIFETON 200 (K800098)Kt Medical, Inc.1980-02-11
COMBISON 200 & COMBISON 202 (K800094)Kt Medical, Inc.1980-02-11
UHR UNIVERSAL6HIP REPLACEMENT (K800207)Osteonics Corp.1980-02-11
AMBIVASON DR-200 (K800096)Kt Medical, Inc.1980-02-11
SEARLE PHO/SONIC ALPHA 2000 (K800139)G.D. Searle and Co.1980-02-11
SEARS BEHIND-THE-EAR HEARING AID (K800113)Int'L Hearing Aids, Inc.1980-02-11
OVALITH P-BP BIPOLAR CARDIAC PACEMAKER (K800194)Coratomic, Inc.1980-02-11
TRANSDUCER (K800093)Kt Medical, Inc.1980-02-11
INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR (K800179)Sphygmetrics, Inc.1980-02-11
MGD-3 (K800095)Kt Medical, Inc.1980-02-11
TELESONIC (HEARING AID) (K800105)Telesonic, Inc.1980-02-11
MINIVASON 9 (K800097)Kt Medical, Inc.1980-02-11
MICRO ELISA MINI READER (K800057)Dynatech Laboratories, Inc.1980-02-11
I.M. BLADES (K800177)Instrument Makar, Inc.1980-02-11
OXFORD EXTERNAL FIXATION SYSTEM (K800184)Downs Surgical , Ltd.1980-02-11
PIPET CALIBRATION KIT (K800062)Streck Laboratories, Inc.1980-02-11
DEXIDE DISPOSABLE PREP STICK W/IODOPHOR (K792270)Dexide, Inc.1980-02-08
ANESTHESIA & HOSPITAL SYRINGE HOLDER (K792520)Medical Innovations Corp.1980-02-07
UNILAB CULTURING SET (K792648)Sybron Corp.1980-02-06
CAPD TRANSFER SET JC9044 (K792651)Travenol Laboratories, S.A.1980-02-06
EXTEMP/EXTEMP-V (K800153)Pharma-Filter, Inc.1980-02-06
TONGUE HOLDER/SALIVA EJECTOR (K800210)Unitek Corp.1980-02-06
CONTINUOUS AMBULATORY DIALYSIS (CAPD) (K791512)Norton Performance Plastics Corp.1980-02-06
RECTAL LEAKAGE INHIBITOR (K792597)Augustin Jones, M.D.1980-02-06
GAMBRO LUNDIA PLATE DIALYZER (K792611)Gambro, Inc.1980-02-06
ROYCO MODEL 951 CELL MIXER (K800104)Royco Instruments1980-02-06
X-FLO (K800110)Contemporary Surgical Systems, Inc.1980-02-06
VIMEDIC SYSTEM TM (K800163)Medical Systems Group of Viskay, Inc.1980-02-05
RMC KNEE METAL SHOE TIBIAL COMPONENTS (K792619)Richard'S Medical Equip., Inc.1980-02-05
PLATELET RETENTION (ADHESION) COLUMNS (K800037)Hemometrix1980-02-05
STORZ SUPER SORB MICRO EYE SPONGE (K800082)Storz Instrument Co.1980-02-05
EMIT TOBRAMYCIN CONTROL (K800151)Syva Co.1980-02-05
PNEUPAC VENTILATOR/RESUSCITATOR #3 (K792456)Pneupac , Ltd.1980-02-05
SIROPORT (K800172)Siemens Corp.1980-02-05
GLUCOSE OXIDASE REAGENT KIT (K800070)Fisher Scientific Co., LLC1980-02-05
COMPRESSOR (K792457)Pneupac , Ltd.1980-02-05
PNEUPAC RESUSCITATOR INSTANT ACTION SET (K792451)Pneupac , Ltd.1980-02-05
KODAK EKTACHEM ELECTROLYTE ANALYZER (K800054)Eastman Kodak Company1980-02-05
IMMUNOGLOBULIN M REAGENT SYSTEM (K800167)Calbiochem-Behring Corp.1980-02-05
PNEUPAC TEST SET, PT.#500-A250 (K792458)Pneupac , Ltd.1980-02-05
CHICK SURGICAL TABLE (K800118)Warner-Lambert Co.1980-02-05
UCA CREAM (K792489)Vanaray Laboratories, Inc.1980-02-05
ECA GEL (K792488)Vanaray Laboratories, Inc.1980-02-05
PERMADYNE POLYETHER RUBBER IMPRESSION (K800031)Espe Dental Products1980-02-05
PLATELET AGGREGATION REAGENTS (K800146)Pacific Hemostasis1980-02-05
BUN REAGENT KIT (K800071)Fisher Scientific Co., LLC1980-02-05
IMMUNOGLOBULIN G REAGENT SYSTEM (K800119)Calbiochem-Behring Corp.1980-02-05
PNEUPAC VENTILATOR/RESUSCITATOR #2 (K792455)Pneupac , Ltd.1980-02-05
ECA CREAM (K792491)Vanaray Laboratories, Inc.1980-02-05
TRANSCUTANEOUS OXYGEN MONITOR (K800073)Biochem International, Inc.1980-02-05
WRIGHT DOW CORNING SOFTGOODS W/DOW (K792269)Dow Corning Wright1980-02-05
SHARPLAN 743, CO2 LASER SURGICAL SYSTEM (K792418)Laser Industries , Ltd.1980-02-05
TECHNICON C/90 SYSTEM (K800121)Technicon Instruments Corp.1980-02-05
BRIOX MODEL-AEROMIST (K800078)Briox Technologies, Inc.1980-02-05
TOTE-BRUSH (K800154)Anja Marketing, Inc.1980-02-05
ASI REAGENT (K800065)Gilford Diagnostics1980-02-05
ELECTRICAL MUSCLE STIMULATOR (EMS) (K800068)Staodynamics, Inc.1980-02-05
UCA GEL (K792492)Vanaray Laboratories, Inc.1980-02-05
ULTRASOFT GOWN (K800124)Mars Mfg Co.1980-02-05
PNEUPAC OXYGEN THERAPY UNIT (K792453)Pneupac , Ltd.1980-02-05
PULSE GENERATOR, MODEL NO. LIT 222 (K792526)Bentley Laboratories, Inc.1980-02-05
EMIT TOBRAMYCIN ASSAY (K800150)Syva Co.1980-02-05
MEDTRONIC PISCES GENERATION II LEAD KIT (K800193)Medtronic Vascular1980-02-05
PNEUPAC RESUSCITATOR INSTANT ACTION SET (K792454)Pneupac , Ltd.1980-02-05
SORIN PULSE GENERATOR MODEL # LIT 214 H (K792565)Bentley Laboratories, Inc.1980-02-05
PNEUPAC VENTILATOR/RESUSCITATOR (K792459)Pneupac , Ltd.1980-02-05
PNEUPAC RESUSCITATOR INSTANT ACTION SET (K792452)Pneupac , Ltd.1980-02-05
MICROPITETTE (K792696)Meridian Diagnostics, Inc.1980-02-01
HANCOCK AORTIC PUNCH (K800122)Hancock Laboratories, Inc.1980-02-01
DIAGNOSTIC INTRAVASCULAR CATHETER (K800171)Flomed, Inc.1980-02-01
DINAMAP RESEARCH MONITOR 1245 (K800025)Applied Medical Research1980-02-01
CONPHAR SURGICAL RAZORR (K791798)Conphar, Inc.1980-02-01
CARDIOPLEGIA ADMINISTRATION SYSTEM CAS (K800135)Bentley Laboratories, Inc.1980-02-01
CORTEX DOUBLE HELIX SAMPLER (K800003)Cortex Research Corp.1980-02-01
MONOJECT PLASTIC DENTAL INJ. SYRINGE (K792541)Sherwood Medical Co.1980-02-01
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