BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ROCHE ONLINE TDM VALPROIC ACID

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC·Product code KWP·December 18, 2014

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    LERADO GLOBAL·Product code KMN·January 28, 2013

    KINETRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·November 30, 2010

    SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 14, 2014

    LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-115/00

    FDA Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·August 16, 2023