BEUDAMED
    23 results · 26ms · 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 ×

    Orthophos S

    FDA 510(k)
    FDA Class 2 ·Radiology

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690127635·AK3 Congruent Insert Trial Size 6, 16mm

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973107880·TRIAL 90-SRK-191616 POLY-MPCS 6X16 RIGHT

    Compression Staple System

    FDA UDI
    TORNIER, INC.·00846832058785·Staple

    BIOPLEX 2200 MMRV IGG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    THE GRAPPLR AND GRAPPLR EXTENDER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 24, 2025

    STEM: M-VIZION PROXIMAL BODY 20MM L 80MM STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 17, 2021

    STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 19, 2022

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 22, 2014

    M2A-MAGNUM PF CUP 58ODX52ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 26, 2013

    SECURE II MED/SURG MED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 1, 2011

    M-VIZION FEMORAL REVISION SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 29, 2025

    M-VIZION FEMORAL REVISION SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 27, 2025

    M-VIZION PROXIMAL BODY HANDLE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·March 28, 2024

    M-VIZION FEMORAL REVISION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LZO·May 28, 2026

    STEM: M-VIZION PROXIMAL BODY 20MM L 50MM LAT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 24, 2021

    M-VIZION INSERTER ROD

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·May 28, 2024

    M-VIZION FEMORAL REVISION SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 16, 2025

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018