Atlas FDA

1978

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

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RecordFirmDate
TRANSFER PIPET (K780592)Abco Dealers, Inc.1978-05-03
TISSUE PULSATOR (K780683)Pulsator Corp.1978-05-03
EARETTE HEARING AID (K780699)Opticon Corp.1978-05-03
HMD-2000 BATTERY-POWERED MINI-DRILL, THE (K780645)Medishield, Inc.1978-05-03
CBR-T3 UPTAKE KIT (K780500)Clinical Bioresearch1978-05-03
GOAT ANTIINFLUENZA ANTISERA AUSSR (K780696)Northeast Biomedical Labs., Inc.1978-05-03
CREATINE PHOSPHOKINASE (CPK) (K780504)Gamma Enterprises, Inc.1978-05-03
EMIT CENTRIFICHEM THYROXINE ASSAY (K780639)Syva Co.1978-05-03
LYPOPROTEIN CHOLESTEROL TEST KIT (K780173)Environmental Chemical Specialties1978-05-03
KOVA TROL III (K780482)Icl Scientific1978-05-03
CARBON DIOXIDE REAGENTS (K780506)Gamma Enterprises, Inc.1978-05-03
GOAT ANTI-INFLUENZA ANTISERA ATEXAS (K780697)Northeast Biomedical Labs., Inc.1978-05-03
LELECTIVE KINETIC SYSTEM-60 (K780464)Hycel, Inc.1978-05-03
HEATING AIDS-MODEL C78A & C78B (K780669)Circle Hearing Instruments, Inc.1978-05-03
QUANTITOPE 125I-FOLATE RADIOASSAY KIT (K780508)Kallestad Laboratories, Inc.1978-05-03
HEARING AID-MODEL 2010 (K780667)Radioear Corp.1978-05-03
SHIELD (K780263)Lorvic Corp.1978-05-03
BIOPHYSICAL MONITORING SYSTEM (K780425)Gould, Inc.1978-04-28
AIR-PWOERED COLDRILL (K780646)Medishield, Inc.1978-04-28
ULTRANOVAR, DENTAL U.V. CURING LAMP (K780518)Demetron Research Corp.1978-04-28
ACCES. ANALOG OUTPUT ADAPTOR MODEL 910 (K780358)Applied Medical Research1978-04-28
CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM (K780526)I M, Inc.1978-04-28
GENTAMICIN RIA KIT (K780516)Antibodies, Inc.1978-04-28
AUTOMATED PHYSIOLOGIC PROFILER (K780530)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-04-28
RADIOASSAY FOR TOTAL SERUM THYROXINE (K780644)Nuclear Diagnostics, Inc.1978-04-28
CLAMP, INCONTINENCE, BAUMRUCKER (K780137)Greenwald Surgical Co., Inc.1978-04-28
IMPRESSION TRAY (K780678)Rocky Mountain Orthodontics, Inc.1978-04-28
DRY SILVER PROCESSOR MODEL 1226 (K780640)Honeywell, Inc.1978-04-28
AORTIC PUMP (K780567)ETHICON, Inc.1978-04-28
UNISTAT OXIMETER (K780625)American Optical Corp.1978-04-28
STIKSEP-T3 KIT (K780486)Nuclear Diagnostics, Inc.1978-04-28
STAC SYSTEM (K780373)Technicon Instruments Corp.1978-04-28
HEARING AID, EARETTE (K780654)Oticon Corp.1978-04-28
GAMMA STIK 125I T3 UPTAKE KIT (K780492)Alpha Gamma Laboratory1978-04-28
RIA SYS. FOR HUMAN LUTEINIZING HORMONE (K780367)Calbiochem-Behring Corp.1978-04-28
AMINOGLYCOSIDE TEST SYSTEM (K772116)Nichols Institute Diagnostics1978-04-28
FIBER OPTIC HANDPIECE (K780483)Syntex Corp.1978-04-28
DAYSTAR SELECTRA & SELECTRA/ORBITER (K780666)Castle Co.1978-04-27
TEMPERATURE INDICATOR (K780580)Respiratory Care, Inc.1978-04-27
HUMIDIFIER FILTER (K780535)Hudson Oxygen Therapy Sales Co.1978-04-27
AQUAPAK PREFILLED HUMIDIFIER (K780562)Respiratory Care, Inc.1978-04-27
BODY WARMER (K780426)Q-Matic Corp.1978-04-27
TOTAL KNEE SYSTEM (K780299)Richard'S Medical Equip., Inc.1978-04-27
SHADOW-CATHS (K780643)Quinton, Inc.1978-04-27
H.P. MEDICAL GRADE SILICONE TUBING (K780470)Dow Corning Corp. Healthcare Industries Materials1978-04-27
COLOPLAST-DURASEAL OSTOMY APPLIANCE (K780409)C.R. Bard, Inc.1978-04-27
LOW IIONIC STRENGTH SOLUTION (K780413)Pfizer, Inc.1978-04-24
QUALITY CONTROL SYSTEM, SPECTRA (K780097)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-04-24
SPECT RIM (LISS) (K780556)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-04-24
NORMAL UNASSAYED CONTROL SERA (K780351)Macomb Chemical Co.1978-04-24
EMIT CARBAMAZEPINE ASSAY (K780466)Syva Co.1978-04-24
THYRO-ZYME-T4 ASSAY KIT (K780401)Coulter Electronics, Inc.1978-04-24
SGOT/AST REAGENT SYSTEM (K780443)American Monitor Corp.1978-04-24
EMIT ANTIEPILEPTIC DRUG CALIBRATORS (K780467)Syva Co.1978-04-24
DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT (K780475)Burroughs Wellcome Co.1978-04-24
DISC-PAK ROTATOR (K780544)Techhnilab Instruments, Inc.1978-04-24
BLOOD FLOWMETER SYSTEM (K780302)Medtronic Vascular1978-04-21
PERCUTANEOUS SHEATH INTRODUCER KIT (K780532)Arrow Intl., Inc.1978-04-21
ELECTRIC RESPONSE AUDIOMETER (K780540)Life-Tech Instruments, Inc.1978-04-21
COLD PACK (K780603)Abco Dealers, Inc.1978-04-21
SNAP-FIT (K780511)E. R. Squibb & Sons, Inc.1978-04-21
DENTAL AMALGAMATOR (K780560)L.D. Caulk Co.1978-04-21
HEALTH SEAT SYSTEM (K780566)G & W Applied Science Laboratories1978-04-21
RATE PROGRAMMER MODEL 520 (K780175)Intermedics, Inc.1978-04-21
THERAPEUTIC APPARATUS, DIERKER TYPE (K770534)Well Being Ent.1978-04-21
PANTRIDGE MK III DEFIBRILLATOR/MONITOR (K780416)Ipco Corp.1978-04-21
DENTAL ROTARY CARBIDE BURS 76EJL (K780641)Teledyne Densco1978-04-21
ACTIVE-LIFE (K780454)E. R. Squibb & Sons, Inc.1978-04-21
HYDRON BURN DISPOSABLE DISPENSER SET (K780616)Abbott Laboratories1978-04-19
HDL REAGENT SET FOR LIPOPROTEINS (K780389)Worthington Biochemical Corp.1978-04-19
NON-STICK PADS (K780549)National Patent Development Corp.1978-04-19
SHAVE PREP (K780604)Abco Dealers, Inc.1978-04-19
INFANT INCUBATOR (K780472)Air-Shields, Inc.1978-04-19
SYRINGE (IRRIGATION) (K780602)Abco Dealers, Inc.1978-04-19
BANDAGE (K780606)Abco Dealers, Inc.1978-04-19
STOPCOCK (K780596)Abco Dealers, Inc.1978-04-19
STOCKINETTE, STERILE (K780612)Abco Dealers, Inc.1978-04-19
NERVTRON-RX (K780444)Medix Corp.1978-04-19
STERILE AIR SYRINGE (K780550)National Patent Development Corp.1978-04-19
PREMIER CARVERS, STYLE #21C & 21D (K780528)Premier Dental Products Co.1978-04-19
IRRIGATION TRAY (K780600)Abco Dealers, Inc.1978-04-19
TUBULAR DRESSING RETAINER (K780570)Alba-Waldensian, Inc.1978-04-19
AUDIO MONITOR-MODEL 8309 (K780538)Life-Tech Instruments, Inc.1978-04-19
IMMUNOZYME E. HISTOLYTICA ANTIGENS (K780114)Millipore Corp.1978-04-19
I.V. ADMINISTRATION SET WITH MINI-SPIKE (K780551)National Patent Development Corp.1978-04-19
TRANSPORTABLE OXYGEN PURITY ANALYZER (K780448)Taylor Instrument Analytics Co.1978-04-19
THERMOMETER KIT (K780591)Abco Dealers, Inc.1978-04-19
MINI-IRRIGATION TRAY (K780595)Abco Dealers, Inc.1978-04-19
SYRINGE, EAR & ULCER (K780599)Abco Dealers, Inc.1978-04-19
SINGLE VIAL LACTATE (K780563)Boehringer Mannheim Corp.1978-04-18
ARRHYTHMIA TREND ENHANCEMENT (K780343)American Optical Corp.1978-04-18
TOURNEQUET, NON-PNEUMATIC (K780429)Hemox, Inc.1978-04-18
ASEPTIC TRANSFER SET (K780417)Heyer Schulte Corp.1978-04-18
PARAMEDIC O2 KIT (K780168)Pohlmann Rescue Products, Inc.1978-04-18
PRECIMAT GLYCEROL (K780439)Boehringer Mannheim Corp.1978-04-18
TRAVELAIR AND STATIONAIR (K780496)Cryomed Corp.1978-04-18
NUCLEAR STETHOSCOPE (K780510)Bios, Inc.1978-04-18
CT/T INDEPENDENT DIAGNOSTIC CENTER (K780480)General Electric Co.1978-04-18
CATHETERIZATION TRAY & KIT (K780259)Argon Medical Corp.1978-04-18
ATROXIN (K780355)Sigma Chemical Co.1978-04-18
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Every clearance here is in the API, with alerts when new ones post.