BEUDAMED
    11 results · 22ms · 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.

    Go Dose System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BICERA (TM) RESORBABLE BONE SUBSTITUTE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PENUMBRA MAX PUMP - INDIGO SYSTEM

    FDA Adverse Event
    Malfunction ·PENUMBRA INC., USA·Product code NRY·August 23, 2018

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·March 8, 2018

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 220

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·April 9, 2018

    CAPSURE SP

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·October 10, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    MAQUET TUBING SET

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTQ·June 16, 2011

    OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 13MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·September 29, 2025

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018