Atlas FDA

1978

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

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RecordFirmDate
THYMUNE-T (K780874)Burroughs Wellcome Co.1978-06-14
PRIMO CEDM (BEHIND THE EAR) (K780918)Argosy Intl. (Usa), Inc.1978-06-14
T4-RIA KIT (K780707)Clinical Bioresearch1978-06-14
PM 25 PP (BODY AID) (K780914)Argosy Intl. (Usa), Inc.1978-06-14
ARTERIOVENOUS BLOOD TUBING SETS (K780681)Extracorporeal Medical Specialities, Inc.1978-06-14
M. 1336S CATHODE-RAY TUBE DISPLAY (K780782)Hewlett-Packard Co.1978-06-14
5543 INDEPENDENT VIEWING SYSTEM (K780930)Emi Medical, Inc.1978-06-14
DIAMOND STONES (K780864)Venture Technology, Inc.1978-06-14
UM VII (BEHIND THE EAR) (K780922)Argosy Intl. (Usa), Inc.1978-06-14
SPHERISTEM TOTAL HIP PROSTHESIS (K780497)American Ortomed Corp.1978-06-14
HYGIENIC ANCHORINGS (K780804)Hygienic Dental Mfg., Co., The1978-06-14
MM-CE DM (BEHIND THE EAR) (K780921)Argosy Intl. (Usa), Inc.1978-06-14
ESTIC MICROFILL (K780833)Degussa Dental, Inc.1978-06-14
M25 PP (BEHIND THE EAR) (K780919)Argosy Intl. (Usa), Inc.1978-06-14
CT5137 HIGH RESOLUTION OPTION (K780928)Emi Medical, Inc.1978-06-14
SGPT/ALT REAGENT SYSTEM (K780791)American Monitor Corp.1978-06-13
MIXING BOWL & SPATULA, DISPOSABLE (K780857)Howmedica Corp.1978-06-13
FRACTURE BRACING (K780892)Hosmer Dorrance Corp.1978-06-13
URIC ACID RAPID STAT KIT (K780827)Pierce Chemical Co.1978-06-13
CAPP TERMINAL DEVICE (K780890)Hosmer Dorrance Corp.1978-06-13
ISOZYME - ID CPK MARKER (K780801)Dade, Baxter Travenol Diagnostics, Inc.1978-06-13
TSH RIA KIT (K780726)Amersham Corp.1978-06-13
NINHYDRIN REAGENT KIT (K780847)Beckman Instruments, Inc.1978-06-13
ARMTROL AND FERMTROL (K780802)Biotron , Ltd.1978-06-13
FIBER OPTIC ADJUSTABLE HEADLIGHT (K780433)Cameron-Miller, Inc.1978-06-13
ESOPHAGEAL MOTILITY SYSTEM - MODEL 3330 (K780812)Honeywell, Inc.1978-06-13
PERALISTIC PUMP MODEL 2000 (K780789)Innovative Medical Systems, Inc.1978-06-13
SOLUTIONS FOR RESPIRATORY THERAPY (K780668)Travenol Laboratories, S.A.1978-06-13
MILK BATH CONCENTRATE (K780258)Sparta Instrument Corp.1978-06-13
TRANSDUCER, PRESSURE, OPTION, H-P, P23ID (K780797)Gould, Inc.1978-06-13
TESTOSTERONE RADIOIMMUNOASSAY KIT 125I (K780792)The Upjohn Co.1978-06-13
URINARY CATHETER CARE SET (K780735)Shield Laboratories, Inc.1978-06-13
VITAMIN B12 RADIOASSAY (K780799)Amersham Corp.1978-06-13
POST-OPERATIVE HIP ORTHOSIS (K780891)Hosmer Dorrance Corp.1978-06-13
GOULD-STATHAM SP1405 PRESSURE MONITOR (K780798)Gould, Inc.1978-06-13
HDL CHOLESTEROL (K780659)Macomb Chemical Co.1978-06-13
VELKET TOURNIQUET (K780594)Abco Dealers, Inc.1978-06-06
NON-STERILE FOLDED GAUZE (K780764)The Owenby Co.1978-06-06
S/D 600 SPHYGMOMANOMETER AND PULSEMETER (K780805)G & W Applied Science Laboratories1978-06-06
125 I-T3 UPTAKE REAGENT (K780671)Radioimmunoassay, Inc.1978-06-06
ICE BAG, VINYL (K780608)Abco Dealers, Inc.1978-06-06
TILL-U-TEST, DIP SLIDE (K780803)Biotron , Ltd.1978-06-06
KRYORACK/4 (K780757)Streck Laboratories, Inc.1978-06-06
GAUZE SPONGES (K780795)Abco Dealers, Inc.1978-06-06
TREND II ANEROID (K780598)Abco Dealers, Inc.1978-06-06
PATIENT LIFT (K780684)Orthopedic Equipment Co., Inc.1978-06-06
AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT (K780783)J.T. Baker Chemical Co.1978-06-06
PLATELET CONTROL (K780714)Bhp Diagnostix, Inc.1978-06-06
125 I-T4 RIA REAGENT (K780672)Radioimmunoassay, Inc.1978-06-06
ELECTRONIC THERMOMETER (K780800)Metek Corp.1978-06-06
CENTRIA CORTISOL RIA (K780725)Union Carbide Corp.1978-06-06
TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT (K780787)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-06-06
DISPOSABLE INFUSION SET (K780559)Ks Medical Supply Co.1978-06-06
PROBE COVER (K780593)Abco Dealers, Inc.1978-06-06
LAS-R HUMAN IGE TEST (K780753)Hyland Therapeutic Div., Travenol Laboratories1978-06-06
RECAP (K780665)Bca Biological Corp. of America1978-06-06
CLIN. CHEM. CONTROL SERUM-QUANTITATE (K780554)Beckman Instruments, Inc.1978-06-06
SUPPLEMENTAL TYGON PAC-MONITORING LINES (K780662)Norton Performance Plastics Corp.1978-06-06
HALOGEN EXAM. LITE #48400 (K780628)Welch Allyn, Inc.1978-06-06
VOLUME CONTROL DEVICE VCD-150 (K780465)Sorensen Research1978-06-02
CT BLANKETS (BOLUS MATERIAL) (K780737)Emi Medical, Inc.1978-06-02
CT 5221 DOSE REDUCING COLLIMATORS (K780736)Emi Medical, Inc.1978-06-02
BUBBLE SUCTION TUBING (K780724)Davol, Inc.1978-06-02
PREVI DENT PROPHYLAXIS MINT NDC (K780834)Hoyt Laboratories1978-06-02
EAR ELECTRODE-ADULT & PEDIATRIC (K780537)Life-Tech Instruments, Inc.1978-06-02
GASTRIC LAVAGE KIT (K780471)Gaymar Industries, Inc.1978-06-02
GAMMA CAMERA (K780855)G.D. Searle and Co.1978-06-02
S-100 CT SCANNER (K780769)Syntex Corp.1978-06-02
HBF-QUIPLATE METHODOLOGY (K780807)Helena Laboratories1978-06-02
ENEMA, PHOSPHATE (K780613)Abco Dealers, Inc.1978-06-02
HEARING AID MODEL 8148 (K780820)Int'L Hearing Aids, Inc.1978-05-31
RTV SILICONE HAND KNEADABLE PUTTY (K780778)Crown Delta Corp.1978-05-31
OUTPUT DIGITAL DISPLAY MODULE, MODEL 401 (K780356)Output, Inc.1978-05-31
MODIFIED UNTREATED TAMPAX TAMPONS (K780648)Tampax, Inc.1978-05-31
HEARING AID MODEL 8160U (K780822)Int'L Hearing Aids, Inc.1978-05-31
NURITE II (K780828)Bio-Medical Systems Corp.1978-05-31
CONTROLLER, SERVO, INSPIRON (K780630)C.R. Bard, Inc.1978-05-31
HEARING AID MODEL 8160H (K780821)Int'L Hearing Aids, Inc.1978-05-31
INSTRUMENT LUBRICANT (K780610)Abco Dealers, Inc.1978-05-31
THERMAJUST CIRCU-TEMP (K780543)Techhnilab Instruments, Inc.1978-05-26
ADVANCED DENTURE SYSTEM (K780722)Advanced Marketing Research Co.1978-05-26
SR-PLUS DIRECT CHOLESTEROL TEST (K780545)Stanbio Laboratory1978-05-26
CULDOCENTESIS TRAY (K780624)Cutter Laboratories, Inc.1978-05-26
MICRO-RING (K780711)Howmedica Corp.1978-05-26
TRIGLYCERIDE C-37 RAPID STAT KIT (K780825)Pierce Chemical Co.1978-05-26
MASK, ISOLATION (K780609)Abco Dealers, Inc.1978-05-26
DYNEX BLOOD GAS QUALITY CONTROL SYS. (K780144)Analytical Products, Inc.1978-05-26
ACCESSORY HDL CHOLESTEROL REAGENT SET (K780638)The Dow Chemical Co.1978-05-26
BILIRUBIN RAPID STAT KIT (K780826)Pierce Chemical Co.1978-05-26
BOTTLE BREATHING DEVICE (K780558)B & F Medical Products, Inc.1978-05-26
FLAME PHOTOMETER, MODEL 455 (K780650)Corning Medical & Scientific1978-05-26
MASSAGER, GUM/SSAGE POWERED GUM (K780360)Sunbeam Corp.1978-05-26
DURAN FLEXIBLE RING (K780568)Hancock Laboratories, Inc.1978-05-26
PROPHYLAXIS ANGLE (K780752)Young Dental Manufacturing Co. 1, LLC1978-05-26
SCINTILLATION, LIQUID, RACKBETA (K780341)Lkb Instruments, Inc.1978-05-26
TOTAL IRON BINDING CAPACITY (K780412)Diagnostic Corp. of America1978-05-26
FLAME PHOTOMETER, MODEL 435 (K780649)Corning Medical & Scientific1978-05-26
ARRHYTHMIA PROGRAM MODULE (K780432)Midwest Analog & Digital, Inc.1978-05-26
VENTURI OXYGEN MASK (K780626)Hospitak, Inc.1978-05-26
SNAP-WAY (K780747)Northwest Orthodontics, Inc.1978-05-26
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Every clearance here is in the API, with alerts when new ones post.