BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VERSANT JUBILEE

    FDA UDI
    FGX INTERNATIONAL INC.·00193033307786·

    LAG SCREW, TI GAMMA3 10.5X95MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 25, 2012

    REX, VERSION 3.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    T:SLIM X2 INSULIN PUMP

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·February 6, 2018

    PULSE GEN MODEL 102

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·November 7, 2008

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 1, 2011

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 16, 2013

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025