BEUDAMED
    12 results · 19ms · 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.

    PATHASSIST LIGHT FIBER

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    DIOPSYS NOVA VEP VISION TESTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    OMNIDOS

    FDA 510(k)
    FDA Class 2 ·Radiology

    FIBULA COMP LOCK PLATE 10H STE

    FDA Adverse Event
    Injury ·BIOMET TRAUMA·Product code HRS·August 24, 2016

    CORONOID PLATE RT STE

    FDA Adverse Event
    Injury ·BIOMET TRAUMA·Product code HRS·June 9, 2016

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·February 15, 2018

    NEXGEN PROLONG CR ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code JWH·May 7, 2013

    DUROM US ACETABULAR COMPONENT 56/50 P

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·May 24, 2011

    HEARTMATE XVE

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·August 11, 2008

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·August 1, 2015

    S3 SHOULDER PLATE 4 HOLE RIGHT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LXT·March 4, 2013

    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