Atlas FDA

1978

1,975 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CPK REAGENT SET (K780070)Medical Analysis Systems, Inc.1978-02-13
ANASWAB (K780159)Scott Laboratories, Inc.1978-02-13
CARDIAC PULSE GENERATOR, MODEL 160B (K780113)Telectronics, Inc.1978-02-13
ULTRAZYME PLUS GOT (K780103)Harleco1978-02-13
CANNULA, ARTERY, RENAL (K780079)Dravon Medical, Inc.1978-02-13
WHEELCHAIR ACCESSORIES (K780184)Orthopedic Equipment Co., Inc.1978-02-13
ESIS MODULE (K780043)Datascope Corp.1978-02-13
TEST SYS. FOR NDNA ANTIBODY DETERM. (K780178)Zeus Scientific, Inc.1978-02-13
TOBRAMYCIN 125I RIA KIT (K780182)New England Nuclear1978-02-13
QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA (K772422)Bio-Rad1978-02-13
ULTRAZYME PLUS HBD (K780104)Harleco1978-02-13
HBDH REAGENT SET (K780073)Medical Analysis Systems, Inc.1978-02-13
WHEELCHAIRS, MECHANICAL (K780183)Orthopedic Equipment Co., Inc.1978-02-13
RECORDER, PAPER, ECG (K772333)Telectronics, Inc.1978-02-13
MASK, SURGICAL (K780169)Convertors1978-02-13
MONITOR, CARDIAC, BEDSIDE (K772332)Telectronics, Inc.1978-02-13
RABBIT ANTIBODY/THYROID STIMUL. HORMONE (K780059)Pcl-Ria, Inc.1978-02-13
THYROXINE STDS. IN HUMAN SERUM (K780050)Pcl-Ria, Inc.1978-02-13
ULTRAZYME PLUS GPT (K780102)Harleco1978-02-13
ULTRAZYME PLUS ALP (K780095)Harleco1978-02-13
IRON BINDING CAPACITY CHEMISTRY (K780094)Harleco1978-02-13
LDH-L REAGENT SET (K780074)Medical Analysis Systems, Inc.1978-02-13
FINGER EXERCISE BOARD (K772404)Fred Sammons, Inc.1978-02-13
RADIATION TREATMENT PLANNING SYSTEM (K780157)Capintec, Inc.1978-02-13
GLUCOSE REAGENT FOR GLUCOSE ANALYZER (K780093)Harleco1978-02-13
NEONATAL SCREENING AUDIOMETER (K780150)Telediagnostic Systems, Inc.1978-02-13
THYRO-INDICATOR T-3 125I (K780018)Clinical Immuno-Diagnostics1978-02-07
IMMUNOPEROXIDASE TEST SYS. FOR ANA SETER (K780161)Zeus Scientific, Inc.1978-02-07
THYROID STIMULATING HORMONE (K780015)Pcl-Ria, Inc.1978-02-07
LACTATE DEHYDROGENASE COLORIMETRIC SUB. (K780080)Corning Medical & Scientific1978-02-07
ULTRACHEM ALBUMIN (K780092)Harleco1978-02-07
ALP REAGENT SET (K780068)Medical Analysis Systems, Inc.1978-02-07
ANESTHESIA TRAY, CAUDAL (K780120)Kendall Research Center1978-02-06
IMPLANT, HINGE TOE, FLEX. (K780132)Dow Corning Corp. Healthcare Industries Materials1978-02-06
ELBOW PROTECTOR (K780171)Stat Medical Corp.1978-02-06
ENDOCARDIAL PACING ELECTRODE (K772309)Coratomic, Inc.1978-02-06
RADIAL IMMUNODIFFUSION KIT-COMPLEMENT (K772075)Gelman Instrument Co.1978-02-03
HUMAN FOLLICLE STIMULATING HORMONE (K780016)Pcl-Ria, Inc.1978-02-03
ANTICONVULSANT CONTROL SERUM (K780142)Mcdonnell Douglas Corp.1978-02-03
RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. (K772076)Gelman Instrument Co.1978-02-03
RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G (K772077)Gelman Instrument Co.1978-02-03
CARDIOMETER (K780117)Med General1978-02-03
RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M (K772079)Gelman Instrument Co.1978-02-03
RADIAL IMMUNODIFFUSION KIT-COMP. 3 (K772073)Gelman Instrument Co.1978-02-03
LAS-R HUMAN ANTITHROMBIN III TEST (K772328)Hyland Therapeutic Div., Travenol Laboratories1978-02-03
RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN (K772074)Gelman Instrument Co.1978-02-03
RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN (K772078)Gelman Instrument Co.1978-02-03
RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT (K772080)Gelman Instrument Co.1978-02-03
HTSH RIA (K780122)Abbott Laboratories1978-02-03
HEMATOLOGY REFERENCE CONTROLS (K772195)R&D Systems, Inc.1978-02-03
LAS-R HUMAN PREALBUMIN TEST (K772329)Hyland Therapeutic Div., Travenol Laboratories1978-02-03
VALVE ANESTHETIC (K771892)Promed Corp.1978-02-02
HYMIDIFIER (K780088)3M Company1978-02-02
ELECTROCARDIOGRAPH TRANSMITTER, 536 (K772186)Intermedics, Inc.1978-02-02
JOSEPH SAW (K772379)Edward Weck, Inc.1978-02-02
CONCHAPAK OXYGEN DILUTER (K780011)Respiratory Care, Inc.1978-02-02
FACELIFT SCISSORS (K780152)Edward Weck, Inc.1978-02-02
BLOOD FILTER, MICROEMBOLI-ATS-F10 (K780145)Sorensen Research1978-02-02
URINARY DRAINAGE MONITORING SYSTEM (K780134)Medical Devices, Inc.1978-02-02
BUBBLE-TYPE OXYGENATOR (K772284)Cobe Laboratories, Inc.1978-02-02
BREATHING CIRCUIT, BAIN (K780044)Respiratory Care, Inc.1978-02-02
MUSCLE STIMULATOR, ELECTRICAL (K780133)De Electronics1978-02-02
HOUSE SUCTION IRRIGATOR (K780153)Edward Weck, Inc.1978-02-02
OXYGENATOR HOLDER (K780056)C.R. Bard, Inc.1978-02-01
SANDBAGS, VARIOUS WEIGHTS (K772414)Fred Sammons, Inc.1978-02-01
ULTRACHEM E-GLU, MANUAL DETERM. (K780065)Harleco1978-02-01
LACTATE DEHYDROGENASE (K780041)Beckman Instruments, Inc.1978-02-01
INTRA-ARTICULAR SHAVER (K771218)Dyonics, Inc.1978-02-01
HYDORRYBUTYRATE DEHYDROGENASE (K780042)Beckman Instruments, Inc.1978-02-01
PNEUMATIC POWERED BUR (K780139)North Palm Beach Orthodepic Assoc.1978-02-01
ALANINE TRANSAMINASE (K780040)Beckman Instruments, Inc.1978-01-31
COLLAR, CERVICAL, SPLIT (K780136)Richard'S Medical Equip., Inc.1978-01-31
DATA ACQUISITION & COLLATING SYS. (K772344)Gilford Instrument Laboratories, Inc.1978-01-31
STAC SYSTEM - ADDITIONAL ANALYTES (K772352)Technicon Instruments Corp.1978-01-31
CEMENT EXTRACTION INSTRUMENT SET (K780135)Orthopedic Equipment Co., Inc.1978-01-31
TILL-U=TEST (K780109)Clinifax Industries, Ltd.1978-01-31
DINAMAP MODEL 850 (K780127)Applied Medical Research1978-01-31
ANTITHROMBIN III ASSAY (K780002)Ortho Diagnostics, Inc.1978-01-31
I.V. CATHETER (K772354)Ndm Corp.1978-01-31
ASPARTATE TRANSAMINASE (K780039)Beckman Instruments, Inc.1978-01-31
BLOOD PRESSURE MONITOR, ARTERIAL (K780128)Applied Medical Research1978-01-31
SPIROMETER, MONITORING W/ALARM (K780064)Ohio Medical Products1978-01-31
PULSE GENERATOR, UNIPOLAR, PROGRAMABLE (K772238)Cardiac Pacemakers, Inc.1978-01-30
SERUM GLUTAMIC OXALOACETIC TRANSAMINASE (K780013)Macomb Chemical Co.1978-01-30
SPECTACLE FRAME, OP-TITE (K772368)Dentsply Intl.1978-01-30
ETHYLENE OXIDE STERILI. INDICATOR (K772358)Bio-Medical Sciences, Inc.1978-01-30
AUTO. SLIDE STAINER (K780017)Honeywell, Inc.1978-01-30
SPECTROPHOTOMETER, MODEL 5000 (K780112)The Perkin-Elmer Corp.1978-01-30
MICROPULSE 22U (K780091)Edwards Pacemaker Systems1978-01-30
SCANNERS, TOMOGRAPHIC, COMPUTED (K780115)Ohio Nuclear, Inc.1978-01-30
CATHETER, CHOLANGIOGRAM, OPERATIVE (K772288)Gesco Intl., Inc.1978-01-30
PULSE GENERATOR, BIPOLAR, PROGRAMMABLE (K772239)Cardiac Pacemakers, Inc.1978-01-30
17-HYDROXY TEST (K772426)Hycel, Inc.1978-01-30
PULSE GENERATOR, BIPOLAR, DEMAND (K772241)Cardiac Pacemakers, Inc.1978-01-30
PULSE GENERATOR, UNIPOLAR, DEMAND (K772240)Cardiac Pacemakers, Inc.1978-01-30
TQC CALIBRATION REFERENCE FOR PLATELETS (K770143)Technicon Instruments Corp.1978-01-30
ANALYZER-PLUG-IN, CO2 MODEL M 3104 (K780107)Electronics For Medicine, Inc.1978-01-30
TDL-100 B (K772050)Pacesetter Systems1978-01-30
CARDIAC PACER, MODEL 208 (K780066)Cordis Corp.1978-01-30
X-RAY CO-ORDINATOR (K772313)Rinn Corp.1978-01-30
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