BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    Voyant 5mm Fusion Device

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT

    FDA 510(k)
    FDA Class 2 ·Dental

    AVITA WRIST TYPE BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PENUMA IMPLANT

    FDA Adverse Event
    Injury ·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019

    VANGUARD ROCC POR FEM S60 L

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JWH·February 3, 2026

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 17, 2013

    NEXGEN ALL POLY PATELLA

    FDA Adverse Event
    Injury ·ZIMMER·Product code HTG·July 20, 2011

    LACTOSORB PECTUS STABILIZER

    FDA Adverse Event
    Other ·BIOMET MICROFIXATION·Product code HRS·September 10, 2008

    VANGUARD MONO FINNED STM TIB 71X8

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JWH·August 9, 2023

    TRULIANT TIB IMP CRC INSERT SZ 3.5, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 25, 2022

    VANGUARD ROCC POR FEM S60 L

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code JWH·February 20, 2025

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021