BEUDAMED
    17 results · 23ms · 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 ×

    COFLEX-F

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MEDISTIM VERIQC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PENCAN®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code BSP·May 6, 2025

    ECHI GREENVILLE NC 2

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011

    ECHI GREENVILLE NC 2

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·November 30, 2011

    STONYBROOK HSP NY NY 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code OEZ·September 15, 2015

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 14, 2013

    ZMR FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWZ·September 10, 2014

    PINN CAN BONE SCREW 6.5MMX15MM

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD.·Product code NDJ·May 19, 2011

    C21785 IT TREVISO

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code GEI·December 14, 2012

    PENCAN®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code BSP·April 10, 2025

    D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTM·May 18, 2022

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·March 3, 2025

    D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTM·March 17, 2022

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025