BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    DENTAL ALLOY

    FDA 510(k)
    FDA Class 2 ·Dental

    Threshold Pedicular Fixation System, Palisade Pedicular Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VENDYS MODEL 5000 B/BC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ATTUNE FB TIB BASE SZ 7 CEM

    FDA Adverse Event
    Injury ·DEPUY IRELAND REG. # 9616671·Product code JWH·April 21, 2014

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·September 26, 2012

    DUAL COOLER/HEATER

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DWC·July 14, 2010

    BLUNT TIP SCREW, 4X40MM

    FDA Adverse Event
    Malfunction ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·January 3, 2022

    Samsung Digital Diagnostic Mobile X-ray System, Model GM85.

    FDA Recall
    Open, Classified ·NeuroLogica Corporation·Product code IZL·December 28, 2023

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019