BEUDAMED
    14 results · 38ms · Sources: EU EUDAMED, US FDA

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    VITROS Immunodiagnostic Products CEA Reagent Pack

    FDA 510(k)
    FDA Class 2 ·Immunology

    ZARGIS ACOUSTIC CARDIOSCAN

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523102273·R CR MAXTM HXL Congruent Tibial Insert Sz C 17mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523145171·R CR UHMWPE Congruent Tibial Insert Sz C 17mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523172559·CR Tibial Insert Trial with Posterior Pin Relie...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101504·R CR E-MAXTM Vitamin E Congruent Tibial Insert ...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523165681·R CR Tibial Insert Trial with Anterior Slot, Sz...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523124510·R CR Tibial Insert Trial Sz C 17mm

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 18, 2008

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·July 22, 2011

    C-QUR MESH

    FDA Adverse Event
    Injury ·ATRIUM MEDICAL CORP.·Product code FTL·July 15, 2013

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024