Atlas FDA

1979

2,434 FDA 510(k) clearances · Clearance year

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RecordFirmDate
DIAGNOSTIC ULTRASOUND SYSTEM (K791298)Xonics Medical Systems, Inc.1979-09-27
CORALENT COAT 125I CORTISOL RADIOIMM. (K791835)Radioassay Systems Laboratories, Inc.1979-09-27
BRAIN HEART INFUSION AGAR 5% SHEEP BLOOD (K791628)Isle Media and Sterile Products, Inc.1979-09-27
BRAIN HEART INFUSION AGAR (K791630)Isle Media and Sterile Products, Inc.1979-09-27
IMPLANTABLE VENTRICULAR-INHIBITED (K791727)Telectronics, Inc.1979-09-27
IMMUCHEM COVALENT COAT SOLID PHASE ASSAY (K791664)Immuchem Corp.1979-09-27
Y & ELBOW W/WO PORTS (K791856)Airlife, Inc.1979-09-26
CORRUGATED FLEXIBLE POLYETHYLENE & EVA (K791821)Airlife, Inc.1979-09-26
AIR INCENTIVE SPIROMETER (K791819)Airlife, Inc.1979-09-26
I.P.P.B. MANIFOLDS & NEB. SING. & DBL (K791820)Airlife, Inc.1979-09-26
WECK RACK (STERILIZING ACCESSORY TRAY) (K791743)Edward Weck, Inc.1979-09-26
EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR (K791751)Edwards Pacemaker Systems1979-09-26
NADH OXIDATION, AST/SGOT (K791679)American Monitor Corp.1979-09-24
GOAT ANTI-HUMAN C-REACTIVE PROTEIN (K791560)Protos Laboratories1979-09-24
AGGLUTINOTEST-LISTERIA (K791459)Volu Sol Medical Industries1979-09-24
AGGLUTINOTEST-TUBERCULOSIS (K791452)Volu Sol Medical Industries1979-09-24
TEMP-GUARD TM (K790948)Gordon Consultants, Inc.1979-09-24
MANNITOL SALT AGAR (K791621)American Laboratory Supply, Inc.1979-09-24
TOXOPLASMA ANTIBODY TEST SYSTEM (K791571)Zeus Scientific, Inc.1979-09-24
INORGANIC PHOSPHORUS REAGENT (K791708)Gilford Diagnostics1979-09-24
AGGLUTINOTEST-SYPHILIS (K791457)Volu Sol Medical Industries1979-09-24
AGGLUTINOTEST-SALMONELLA (K791450)Volu Sol Medical Industries1979-09-24
ERIKA HPF 100 (K791320)Erika, Inc.1979-09-24
ANTI-NUCLEAR ANTIBODY TEST (K791493)Meloy Laboratories, Inc.1979-09-24
COLUMBIA AGAR WITH5% SHEEP (K791622)American Laboratory Supply, Inc.1979-09-24
HEEL/ELBOW PROTECTORS (K791709)Fibre Formations, Inc.1979-09-24
HERPES EIA TEST KIT (K791397)Microbiological Assoc.1979-09-24
ORTHO TSH RIA KIT (K791301)Ortho Diagnostics, Inc.1979-09-24
COULTER ACCU-ZYME II ENZYMATIC REAGENT (K791640)Coulter Electronics, Inc.1979-09-24
TRYPTIC SOY AGAR 5% SHEEP BLOOD (K791620)American Laboratory Supply, Inc.1979-09-24
AGGLUTINOTEST-STAPHYLOLISIN (K791453)Volu Sol Medical Industries1979-09-24
AGGLUTINOTEST-TOXOPLASMOSIS (K791456)Volu Sol Medical Industries1979-09-24
THE GALASSIA SYSTEM (K791191)Ariel1979-09-24
HYPERDERMIC NEEDLE WITH SENSOR #514 (K791462)Medtech Intl., Inc.1979-09-24
CONTRO I (K791695)Hi Chem, Inc.1979-09-24
GLUCOSE OXIDASE REAGENT SET (K791669)Macomb Chemical Co.1979-09-24
AGGLUTINOTEST-BRUCELLA (K791449)Volu Sol Medical Industries1979-09-24
PROCAST (K791831)Medical Specialties, Inc.1979-09-24
AGGLUTINOTEST-PERTUSSIS (K791454)Volu Sol Medical Industries1979-09-24
AO TEACHING ATTACHMENT, MODEL TA-1 (K791635)American Optical Corp.1979-09-24
MUELLER-HINTON AGAR (K791624)American Laboratory Supply, Inc.1979-09-24
CONTRO II (K791696)Hi Chem, Inc.1979-09-24
BETA-CELL (K791607)Biologics Intl., Inc.1979-09-24
AGGLUTINOTEST-ECHINOCOCCOSIS (K791451)Volu Sol Medical Industries1979-09-24
SYSTEM CONTROLLER 720 SERIES (K791661)Waters Assoc., Inc.1979-09-24
LUKENS BONE WAX (GAMMA RADIATION) (K791495)Lukens Corp.1979-09-24
ERIKA HPF 300 (K791322)Erika, Inc.1979-09-24
SGPT REAGENT SET MODIFICATION (K791641)American Monitor Corp.1979-09-24
ERIKA HPF 200 (K791321)Erika, Inc.1979-09-24
CONPHAR ADAPT-CONNECTS STERILE, NONSTE. (K791806)Conphar, Inc.1979-09-21
CONPHAR UMBILICAL CORD CLAMP (K791800)Conphar, Inc.1979-09-21
SELF CHECK (K791762)Instromedix, Inc.1979-09-21
EMISONIC 4290 (K791429)Emi Medical, Inc.1979-09-21
CONPHAR CATHETER PLUG (K791803)Conphar, Inc.1979-09-21
CONPHAR TUBE CLAMPS (K791802)Conphar, Inc.1979-09-21
CONPHAR FINGERTIP SUCTION CONTROL (K791801)Conphar, Inc.1979-09-21
AF/SYSTEM (K791192)Ariel1979-09-20
PROGRAMMER, MEDTRONIC MODEL 5984/5985 (K791181)Medtronic Vascular1979-09-20
MODEL 221 PROGRAMALITH PULSE GENERATOR (K790873)Pacesetter Systems1979-09-20
TUBE-STRAP (K791781)Olympic Medical Corp.1979-09-19
MEDTRONIC MODEL 6957 (K791769)Medtronic Vascular1979-09-19
ANGIOTENSIN CONVERTING ENZYME ASSAY SYS (K791712)Ventrex Laboratories, Inc.1979-09-19
SCOTTS SURGICAL RETRACTOR AND ELASTIC (K791665)Lone Star Medical Products, Inc.1979-09-19
VA 1000 (K791380)Vitatron Medical BV1979-09-19
MODEL 344 (K791506)Telex Communications, Inc.1979-09-19
DAHLBERG HEARING AID MODEL UN (K791311)Dahlberg Electronics, Inc.1979-09-19
RESPIRATOR DISCONNECT ALARM CR201 (K791527)Intersect Medical Products, Inc.1979-09-19
RESPIRATOR DISCONNECT ALARM VA-100 (K791561)Intersect Medical Products, Inc.1979-09-19
ROYCO MODEL 371 SUPER DILUTOR (K791644)Royco Instruments1979-09-19
AMALGAMATOR MODEL SDC-- (K791410)Sierra Laboratories, Inc.1979-09-19
BARD BIOMEDICAL NERVE LOCATOR (K791442)C.R. Bard, Inc.1979-09-19
IMPLANTABLE ENDOCARDIAL SCREW-IN ELEC (K791732)Oscor, Inc.1979-09-19
IMPLANTABLE PULSE GENERATOR PACEMAKERS (K791568)Intermedics, Inc.1979-09-19
MEROCEL INSTRUMENT WIPE (K791736)Xomed, Inc.1979-09-19
VICKERS MEDICAL MODEL 130 NEAVENT-NEO (K791713)Vickers America Medical Corp.1979-09-19
LINDE OXYGEN CONCENTRATOR LOC-II (K791437)Union Carbide Corp.1979-09-19
CONPHAR AIRWAYS (K791799)Conphar, Inc.1979-09-19
VENTRICULAR LEAD, MODEL 6959 (K790143)Medtronic Vascular1979-09-19
OHIO MODULAR ANESTHESIA GAS MACHINE (K791530)Ohio Medical Products1979-09-19
MODEL G-61 ULTRASONIC DENTAL UNIT (K791585)Cavitron Corp.1979-09-19
CHOLORDE REAGENT (K791690)Hi Chem, Inc.1979-09-17
ADAC TOMOGRAPHY OPTION (K791055)Adac Laboratories1979-09-17
PHENYLALANINE AGAR (K791590)Isle Media and Sterile Products, Inc.1979-09-17
125I LEUTINIZING HORMONE RIA KIT (K791405)Diagnostic Products Corp.1979-09-17
MOTILITY TEST MEDIUM (K791591)Isle Media and Sterile Products, Inc.1979-09-17
NORMAL CONTROL (K791654)Electrophoresis Corp. of America1979-09-17
ANAEROBIC BRUCELLA LAKED BLOOD AGAR (K791563)Anaerobe Systems1979-09-17
TRANSPORT MEDIUM AMIES WITHOUT CHARCOAL (K791543)Isle Media and Sterile Products, Inc.1979-09-17
SODIUM/POTASSIUM BUFFER SOLUTION (K791692)Hi Chem, Inc.1979-09-17
UC-2000 UTERINE CATHERIZATION SYSTEM (K791633)Life Support, Inc.1979-09-17
BAIRD-PARKER AGAR (K791595)Isle Media and Sterile Products, Inc.1979-09-17
TRANSGROW (K791554)American Laboratory Supply, Inc.1979-09-17
GLUCOSE REAGENT (K791685)Hi Chem, Inc.1979-09-17
VENTRE/SEP T4 TEST SET (K791368)Ventrex Laboratories, Inc.1979-09-17
MODEL 54 FLOWMETER BACK-PRESSURE TUBE (K791648)Harris Calorific1979-09-17
ENZYME STABILIZING REAGENT (ESR) (K791656)Electrophoresis Corp. of America1979-09-17
ROUND WASHBASIN & RECTANGLE WASHBASIN (K791348)General Clinical Plastics Corp.1979-09-17
ANAEROBIC BRUCELLA BLOOD AGAR (K791562)Anaerobe Systems1979-09-17
THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR (K791542)Isle Media and Sterile Products, Inc.1979-09-17
SODIUM/POTASSIUM CONDITIONING SOLUTION (K791691)Hi Chem, Inc.1979-09-17
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