BEUDAMED
    10 results · 31ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    EASY TOUCH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    8200 VALVE

    FDA UDI
    HANS RUDOLPH, INC.·00817136020099·8277C INF/BAL VLV LESS HCNTRL

    SYNTHES STERNAL ZIPFIX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 9, 2025

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·May 14, 2013

    PFC SIGMARP STB TB IN 4 10.0

    FDA Adverse Event
    Injury ·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code NJL·May 18, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 15, 2008

    EQUINOXE REVERSE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·October 18, 2022

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021