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

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    EXPEDIUM SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TERUMO NEEDLE WITH LOCKING SHEATH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MYALLERGYTEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 25, 2025

    TEXTURED SILICONE BREAST IMPLANT

    FDA Adverse Event
    CUI·Product code FTR·April 16, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 19, 2011

    RSVR MMT-326A 10PK PRDGM 1.8ML 13L

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code FMF·June 30, 2008

    TRULIANT TIB IMP PS INSERT SZ 2.5 10MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·March 25, 2024

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012