Atlas FDA

1980

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

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RecordFirmDate
MICRO ELISA AUTO READER (K800522)Dynatech Laboratories, Inc.1980-03-25
SERTROL PRODUCT # ACS ST 101 (K800559)Analytical Control Systems, Inc.1980-03-25
BLOM-SINGER DUCKBILL VOICE PROSTHESIS (K800563)Bivona Medical Technologies1980-03-25
DISPOSABLE HAND HELD NEBULIZER (K800562)Intec Medical, Inc.1980-03-25
SUSI II PACEMAKER SURVEILLANCE MONITOR (K792602)Ela Medical, Inc.1980-03-25
LIPID CONTROL PRODUCT # ACS LC 101 (K800558)Analytical Control Systems, Inc.1980-03-25
AXIOM VESSEL LOOPS (K800015)Axiom Medical, Inc.1980-03-25
HMB-200 (K800250)Associated Mills, Inc.1980-03-25
CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA. (K800320)Amersham Corp.1980-03-25
ELECTRONIC CLINICAL THERM. MODEL 811A (K800512)Y1980-03-25
LASER BACKPOINTER ASSEMBLY, MOD. 01-2487 (K800489)Atc Medical Technology, Inc.1980-03-25
ADT DISPOSABLE THIN NEEDLE(SKINNY CHIBA) (K800416)A.D.T. Lab Industries1980-03-25
ADT PERITONEAL LAVAGE TRAY (DISP.) (K800421)A.D.T. Lab Industries1980-03-25
ADULT ANESTHESIA BREATHING CIRCUITS . . (K800498)Airlife, Inc.1980-03-25
STAT TEMP MODEL 4800 (K800396)Baessler Medical Electronics,Inc.1980-03-25
IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD. (K800603)Telectronics, Inc.1980-03-25
ORTHODONTICARTIDE (K800458)European Orthodontic Products1980-03-25
PEDIATRIC ANESTHESIA BREATHING CIRCUITS (K800499)Airlife, Inc.1980-03-25
DIFFERENTIAL REFRACTIVE INDEX DETECTOR (K800556)Hewlett-Packard Co.1980-03-25
CONNECTING TUBES (K800509)Medi-Craft , Ltd.1980-03-25
IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC (K800573)Telectronics, Inc.1980-03-25
HELENA RISTOCETIN (K800432)Helena Laboratories1980-03-25
WATER JEL FIRE BLANKET (K800064)Trilling Resources, Ltd.1980-03-25
BUNN VOLUMAIRE RESPIRATORY EXERCISER (K800546)The John Bunn Co.1980-03-25
MODEL 52 BUNN DRY AIR SUPPLY (K800534)Greene & Kellogg, Inc.1980-03-25
MAGNESIUM REAGENT (K800327)Alta Diagnostics, Inc.1980-03-25
TRIGLYCERIDES TEST (500NM) (K800551)Reagents Applications, Inc.1980-03-25
ADT PERCUTANEOUS TRANSHEPATIC DISP. CHOL (K800419)A.D.T. Lab Industries1980-03-25
MEDISTOR III LUNG ANALYZER (K800547)Cybermedic, Inc.1980-03-25
ADT PERCUTANEOUS NON-DISP. NEEDLE (K800420)A.D.T. Lab Industries1980-03-25
BARNES-HOND HARD CONTACT LENS STOR. CASE (K800582)Barnes-Hind, Inc.1980-03-25
CENTRIFICHEM BUN (K800529)Union Carbide Corp.1980-03-20
MONEL 80&90 ULTRAVIOLET-VISIBLE SPEC. (K800523)Varian Assoc., Inc.1980-03-20
PRI. PIGGYBACK I.V. W/DUAL PIERCING PIN (K800137)Abbott Laboratories1980-03-20
TOBRAM E.R.A. TM (K800517)P-L Biochemicals, Inc.1980-03-20
LIQUID-STAT LIQUID REAGENT (K800457)Beckman Instruments, Inc.1980-03-20
UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA, (K800518)Kopharm, Inc.1980-03-20
CORNING TRANSPHOR (K800544)Corning Medical & Scientific1980-03-20
PHOTOVOLT PVA 4M+2 ANALYZER (K800453)Photovolt Corp.1980-03-20
DAHLBERG #AZ BEHIND THE EAR HEARING AID (K800571)Dahlberg Electronics, Inc.1980-03-20
ZEISS DISPOSABLE, STERILE SURGICAL DRAPE (K800552)Carl Zeiss, Inc.1980-03-20
RIA PHASE T4 (K800203)Boehringer Mannheim Corp.1980-03-19
TRYPTIC SOY BROTH W/C02,CYSTEINE & 1% (K800429)Abbott Laboratories1980-03-19
RIA PHASE TBG (K800204)Boehringer Mannheim Corp.1980-03-19
ANTIBODY TO RUBELLA VIRUS (K792635)Electro-Nucleonics Laboratories, Inc.1980-03-19
CHARCOAL YEAST EXTRACT(CYE) AGAR (K792675)Remel Co.1980-03-19
SMAC SYSTEM, T4 METHOD (K800384)Technicon Instruments Corp.1980-03-19
POWER PACK (K800314)Black & Decker(Tm)1980-03-19
BEHIND EAR HEARING AID MODEL E24C1 (K800244)Oticon Corp.1980-03-19
DUAL MPC CHARGER (K800315)Black & Decker(Tm)1980-03-19
CEPH LACTAM DISK (K800287)Remel Co.1980-03-19
REFRIG. CENTRIFUGE (DRUCKER MODEL) (K800381)Coulter Electronics, Inc.1980-03-19
ULTRASONIC FLOWMETER (K800087)The Perkin-Elmer Corp.1980-03-19
CARDIOPLEGIA DELIVERY SYSTEM (K800377)3M Health Care, Sarns1980-03-19
STIM-EX 201 (K800486)Th Charters, Inc.1980-03-19
SMITH'S SYSTEMIC FUNGAL MEDIUM (K792715)Meridian Diagnostics, Inc.1980-03-19
T3 SOLID PHASE RADIOIMMUNOASSAY KIT (K800436)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-03-19
RIA PHASE DIGOXIN (K800205)Boehringer Mannheim Corp.1980-03-19
PHENCYCLIDINE DIRECT BLOOD RIA KIT (K800514)Immunalysis Corporation1980-03-19
HEPCON/SYSTEM RC-10 (K800161)Hemotec, Inc.1980-03-19
TRYPTIC SOY BROTH(TSB) W/C02 & 1% YEAST (K800426)Abbott Laboratories1980-03-19
TRYPTIC SOY BROTH W/CYSTEINE AND (K800428)Abbott Laboratories1980-03-19
VARIOUS REAGENTS FOR BLOOD CELL ANALYZER (K800180)Laboratory Products, Inc.1980-03-19
ANALYTE T4-THYROXINE (K800385)Technicon Instruments Corp.1980-03-19
DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM. (K800516)E.I. Dupont DE Nemours & Co., Inc.1980-03-19
TRYPTIC SOY BROTH W/C02,SPS&1% YEAST EXT (K800427)Abbott Laboratories1980-03-19
PERCUTANEOUS INTRODUCER SET (K800462)Medical Components, Inc.1980-03-19
DENTAL STOOLS, #'S P2212, P1121, ETC. (K800520)Vacudent Sales Corp.1980-03-18
SUCTION CATHETER (K800503)Medi-Craft , Ltd.1980-03-18
VINYL POLYSILOXANE IMPRESSION MATERIAL (K800485)3M Company1980-03-18
SUPERSIL (K800548)Harry J. Bosworth Co.1980-03-18
OXYGEN CONNECTING TUBES (K800504)Medi-Craft , Ltd.1980-03-18
VSM-1 PHYSIOLOGICAL MONITOR (K800492)Physio-Control Corp.1980-03-18
NEW JERSEY HEMIARTHROPLASTY SHOLDER PROS (K800494)Depuy, Inc.1980-03-18
SMR H-CHAIR (K800526)Surgical Mechanical Research, Inc.1980-03-18
EMERGIENCY RESUSCITATOR/INHALOR W/ASPIR. (K800456)Khi, Inc.1980-03-18
FES ORTHOSIS MODEL NO. 2000 (K800380)Empi1980-03-17
ARISTOSURG 250 (K800395)Halmon-Locren, Inc.1980-03-17
CARPENTIER-EDWARDS FLEX. ANNULOPLASTY (K792441)Edwards Laboratories1980-03-17
DENTSPLY DENTURE CLEANER (K800166)Dentsply Intl.1980-03-17
RITTER MODEL H COMPANION STOOL (K800276)Sybron Corp.1980-03-17
AUTOSCAN 3 (K792647)Cnr Labs1980-03-17
ARCOLITH 3021-CARDIAC PULSE GENERATOR (K800326)Arco Medical Products Co.1980-03-17
AMERLEX T-3 RIA KIT (K800374)Amersham Corp.1980-03-12
CAMPYLOBACTER SELECTIVE SUPPLEMENT (K800267)Oxoid U.S.A., Inc.1980-03-12
MYCOPLASMA SUPPLEMENT G (K800253)Oxoid U.S.A., Inc.1980-03-12
MAXUM DENTURE RESIN (K800400)Dentsply Intl.1980-03-12
STREPTOCOCCUS SUPPLEMENT (K800260)Oxoid U.S.A., Inc.1980-03-12
DERMASEL SUPPLEMENT (K800261)Oxoid U.S.A., Inc.1980-03-12
ADT MINI PERITONEAL LAVAGE KIT (K800422)A.D.T. Lab Industries1980-03-12
CK/LD ISOENZYME CONTROL PROD. #ACS CT101 (K800370)Analytical Control Systems, Inc.1980-03-12
STERILE GC SUPPLEMENT (W/O ANTIBIOTICS) (K800255)Oxoid U.S.A., Inc.1980-03-12
BUN REAGENT (K800341)Gilford Diagnostics1980-03-12
BOND ELUT COLUMNS (K800061)Analytichem International, Inc.1980-03-12
PERFRINGENS SUPPLEMENT A (K800262)Oxoid U.S.A., Inc.1980-03-12
SUSCEPTIBILITY DISK, CINOXACIN 100 MCG. (K792349)Pfizer, Inc.1980-03-12
INFRASONDE D4000 ELECTRONIC B-P MONITOR (K800401)Sphygmetrics, Inc.1980-03-12
FERRIS BONE MARROW BIOPSY-ASPIR. NEEDLE (K800406)A.D.T. Lab Industries1980-03-12
STERILE DRESSING PACK (K800490)Medi-Spec1980-03-12
FLUID DISPENSING SYSTEM (K800362)Pharmaseal Laboratories1980-03-12
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Every clearance here is in the API, with alerts when new ones post.