Atlas FDA

1978

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

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RecordFirmDate
STANICOR THETA MODEL 221 CARDIAC PACER (K780453)Cordis Corp.1978-06-30
AUTO-CON (K781007)Barnes-Hind, Inc.1978-06-30
DX TOOTHBRUSH (K781018)Lever Brothers Company, Inc.1978-06-30
PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX (K781035)Premier Dental Products Co.1978-06-30
ACU-TEST IN-HOME PREGNANCY TEST (K781049)Williams, the J.B. Co., Inc.1978-06-29
CLINICAL ANALYZER SYSTEM (K780903)Bausch & Lomb, Inc.1978-06-28
HEARING AID (K781033)Phonemics, Inc.1978-06-28
ELECTROENCEPHALOGRAPH ACCUTRACE 100 (K781041)Beckman Instruments, Inc.1978-06-28
ISOTONIC DILUENT (K781008)Mallinckrodt Critical Care1978-06-28
PREFORMED TOOTH POSITIONER (K780619)Tp Laboratories, Inc.1978-06-28
SOFT LENS INSERTER (K780931)Soft-Sert1978-06-28
SYSMEX PLATELET COUNTER, PL-110 (K780911)Toa Medical Electronics USA, Inc.1978-06-28
ELECTROENCEPHALOGRAPH ACCUTRATE 200 (K781005)Beckman Instruments, Inc.1978-06-28
THERMO SET ELECTRONIC TEM. CONTROLLER (K780888)Gilford Instrument Laboratories, Inc.1978-06-28
IMMUNOZYME TOXOPLASMA ANTIBODY (K780352)Millipore Corp.1978-06-28
DILUTER/DISPENSER (K780882)Innovative Medical Systems, Inc.1978-06-28
ADJUSTABLE DISPENSOR (K780912)Oxford Laboratories, Inc.1978-06-28
SYSTEM AUTO. BLOOD CELL COUNTER CC-110 (K780910)Toa Medical Electronics USA, Inc.1978-06-28
SOF-WICKLAP PAD (K780718)Johnson & Johnson Professionals, Inc.1978-06-28
AUTOMATED ELECTROPHORESIS SYSTEM (K780901)Olympus Corp.1978-06-28
ECG PAPER, 3 CHANNEL (K780597)Abco Dealers, Inc.1978-06-28
SYSMEX AUTO. BLOOD CELL COUNTER, CC-120 (K780909)Toa Medical Electronics USA, Inc.1978-06-28
OTOSCOPE, DIAG. MODELS 20100 & 20200 (K781029)Welch Allyn, Inc.1978-06-28
IDI GDR DATA REDUCTION SYSTEM (K780813)Iso-Data, Inc.1978-06-28
SAFETY SPRING GUIDES, TEFLON COATED (K780438)C.R. Bard, Inc.1978-06-28
DENTAL AIR BRUSH (K780460)M. Joel Gebhart, D.D.S.1978-06-28
FISHER SPECTROPHOTOMETER (K780902)Bausch & Lomb, Inc.1978-06-28
X-RAY SYSTEM (K780963)General X-Ray, Inc.1978-06-27
X-RAY FRAME HOLDER (K780999)Great Eastern Lumber Co., Inc.1978-06-27
GAMMA CAMERA (K780969)Machlett Laboratories, Inc.1978-06-27
ULTRASONIC IMAGER (K780876)Air-Shields, Inc.1978-06-27
ELECTROSURGICAL GROUNDING PAD CABLE (K780924)Johnson & Johnson Professionals, Inc.1978-06-22
KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT (K780982)Cis Radiopharmaceuticals, Inc.1978-06-22
SINGLE USE ACTIVE ELECTRODE HANDLE (K780978)Aspen Laboratories, Inc.1978-06-22
URIC ACID REFERENCE SERA (K780447)Macomb Chemical Co.1978-06-22
ANTICONVULSANTS II CALIBRATOR KIT (K780734)Vitek Systems, Inc.1978-06-22
ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM (K780913)Beckman Instruments, Inc.1978-06-22
CLINICAL ACQUISITION MODULE (K780971)Analytical Development Assoc. Corp.1978-06-22
MASK, SURGEONS (K780607)Abco Dealers, Inc.1978-06-22
COMPUTERIZED AXIAL TOMOGRAPHY (K780995)Emi Medical, Inc.1978-06-22
SYSING AND HEMOGLOBIN REAGENT (K780829)Harleco1978-06-22
PIEZOMATIC ULTRASONIC SCALER (SYSTEM S) (K780808)Dental Ventures of America, Inc.1978-06-22
SINGLE USE BALL ELECTRODE (K780976)Aspen Laboratories, Inc.1978-06-22
LAPAROTOMY SPONGE (K780818)Qualtex, Inc.1978-06-22
AUTO SUTURE DISPOSABLE STAPLING INSTRU. (K780695)United States Surgical, A Division of Tyco Healthc1978-06-22
PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE (K780858)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-06-22
ANTICONVULSANTS III CALIBRATOR KIT (K780733)Vitek Systems, Inc.1978-06-22
MIC-2000 (K780907)Gibco Laboratories Life Technologies, Inc.1978-06-22
SINGLE USE NEEDLE ELECTRODE (K780975)Aspen Laboratories, Inc.1978-06-22
RIA SYSTEM FOR HUMAN F-S HORMONE (K780870)Calbiochem-Behring Corp.1978-06-22
LAPOROTOMY SPONGE (K780806)Abco Dealers, Inc.1978-06-22
IDI 200 GAMMA COUNTER (K780790)Iso-Data, Inc.1978-06-22
IMPROVED DISPOSABLE HYPODERMIC NEEDLE (K780887)Pharmaseal Div., Baxter Healthcare Corp.1978-06-22
PROSTHESIS, HIP, CATHCART, SCHILLER MOD. (K780773)Depuy, Inc.1978-06-22
LEE-ALLOY (K780967)Lee Pharmaceuticals1978-06-22
NEW RESTODENT (K780965)Lee Pharmaceuticals1978-06-22
SCISSORS, HOOK, ELECTROSURGICAL (K780955)Kli1978-06-22
DENTAL ABRASIVE DEVICE (K780811)Cavitron Corp.1978-06-22
ZYTRON (K780796)Premier Dental Products Co.1978-06-22
510 BEDSIDE X-RAY SYSTEM (K780947)Union Carbide Corp.1978-06-22
SCISSORS, HOOK, ELECTROSURGICAL (K780954)Kli1978-06-22
SINGLE PATIENT SYSTEMS (K780682)Extracorporeal Medical Specialities, Inc.1978-06-22
IRRIGATION CATHETER (K780788)Shiley, Inc.1978-06-22
KNEE, TOTAL, FEMORAL & TIBIAL (K780904)Depuy, Inc.1978-06-22
EB-VCA, TEST, ANTIBODY, FLUORESCENT (K780925)Litton Bionetics1978-06-22
DETECTOR, BUBBLE & FOAM (K780582)Hospal Medical Corp.1978-06-22
PHONIC EAR (K780936)Hc Electronics1978-06-22
SINGLE USE BLADE ELECTRODE (K780977)Aspen Laboratories, Inc.1978-06-22
SYSTEM, PLANNING, TREATMENT (K780948)Emi Therapy Systems, Inc.1978-06-22
ARANTROL (K780835)Aranco Diagnostic Laboratories, Inc.1978-06-22
STIMULATOR MODEL 8021 (K780539)Life-Tech Instruments, Inc.1978-06-22
OTOLOGICAL VENTILATION TUBES (K780956)Mcghan Medical Corp.1978-06-22
EMIT CLINICAL PROCESSOR - CP 5000 (K780881)Syva Co.1978-06-22
THERA-PAK (K780452)Hydro-Med Products, Inc.1978-06-21
LIQUID CRYSTAL DISPLAY DIGITAL WATCH (K780445)Hughes Aircraft Co.1978-06-19
CLINICAL GRAPHICS ANALYZER (K780468)Numonics Corp.1978-06-19
BLOOD PUMP MODEL 7000 (K780942)3M Health Care, Sarns1978-06-19
SELF-RETAINING ELECTRODE SER. #4000-100 (K780908)Andover Medical, Inc.1978-06-19
DRAPING MATERIAL, COLBALT 60 STERILE (K780846)Kimberly-Clark Corp.1978-06-19
BIOSTATOR GLUCOSE ANALYZER (K780393)Miles Laboratories, Inc.1978-06-19
GRAB BAR (K780935)Orthopedic Equipment Co., Inc.1978-06-19
B-HCG-RIA (K780679)Nuclear Medical Systems, Inc.1978-06-14
L-12, L-21, AND L-22 ELECTRODES (K780569)Coratomic, Inc.1978-06-14
DILUTOR TRANSPORTER (K780785)Hyland Therapeutic Div., Travenol Laboratories1978-06-14
NERVE APPROXIMATER (K780289)Edward Weck, Inc.1978-06-14
PRIMO CE (BEHIND THE EAR) (K780917)Argosy Intl. (Usa), Inc.1978-06-14
EXTRACORPEAL CARDIOTOMY BLOOD FILTER (K780653)Cobe Laboratories, Inc.1978-06-14
780 UE (BEHIND THE EAR) (K780916)Argosy Intl. (Usa), Inc.1978-06-14
ISOTONIC BUFFERED SALINE (K780830)Harleco1978-06-14
TECHNICON BGII ANALYZER (K780716)Technicon Instruments Corp.1978-06-14
780 SE (BEHIND THE EAR) (K780915)Argosy Intl. (Usa), Inc.1978-06-14
ESTILUX MICROFILL (K780832)Degussa Dental, Inc.1978-06-14
MM-CE 11 (BEHIND THE EAR) (K780920)Argosy Intl. (Usa), Inc.1978-06-14
MLA ELECTRA 750 COAGULATION TIMER (K780810)Medical Laboratory Automation Systems, Inc.1978-06-14
DENTURE RELINE MATERIAL (K780786)Dentsply Intl.1978-06-14
THYMUNE-M (K780873)Burroughs Wellcome Co.1978-06-14
NEONATAL MONITOR (K780754)Applied Medical Research1978-06-14
ARTERIAL LINE KIT (K780871)Argon Medical Corp.1978-06-14
CRYOCYTE PACK (K780354)Travenol Laboratories, S.A.1978-06-14
PODIATRIC MATERIAL (K780391)Crown Delta Corp.1978-06-14
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Every clearance here is in the API, with alerts when new ones post.