BEUDAMED
    16 results · 25ms · 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 ×

    TubaVent Balloon Dilatation System

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Neodent Implant System - Mini Abutment 60°

    FDA 510(k)
    FDA Class 2 ·Dental

    GMK SPHERE CEMENTLESS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·May 25, 2026

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2024

    GMK 3D METAL TIBIAL TRAY

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 12, 2025

    GMK SPHERIKA CEMENTLESS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·March 16, 2026

    AIR OPTIX FOR ASTIGMATISM

    FDA Adverse Event
    Injury ·PT CIBA VISION BATAM·Product code LPM·October 29, 2014

    GMK FEMORAL CUTTING GUIDE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·July 28, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 12, 2013

    GMK SPHERIKA CEMENTLESS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 19, 2025

    GMK SPHERIKA CEMENTLESS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 24, 2025

    GMK 3D METAL TIBIAL TRAY

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 11, 2025

    GMK 3D METAL TIBIAL TRAY

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 29, 2025

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026