BEUDAMED
    20 results · 22ms · Sources: EU EUDAMED, US FDA

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    ACTIVATOR V-E

    FDA 510(k)
    FDA Unclassified ·Unknown

    AVS ANCHOR-C CERVICAL CAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL THIGH-HIGH SCD SLEEVES, MEDIUM,SMALL, LARGE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 2/12 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 3, 2022

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 2/12 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 28, 2024

    MAINFRAME 8253001 NIM RESPONSE 3.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·February 24, 2014

    EMG TUBE 8229737 3PK NIM TRIVANTAGE 7MM

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code ETN·November 12, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013

    NEXGEN LPS-FLEX ARTICULAR SURFACE

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

    ADAPTA DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NVZ·June 3, 2011

    NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·July 19, 2016

    NIM® 3.0 MAINFRAME

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ETN·January 14, 2015

    NIM® 3.0 MAINFRAME

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ETN·August 15, 2016

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Malfunction ·MENTOR TEXAS·Product code FTR·January 8, 2026

    NIM® PROBE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·March 23, 2018

    NIM® PROBE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·May 11, 2015

    Accu-Chek Ultraflex-2 infusion set; 10 mm 31'' (80 cm); Catalog number INF 04540964001.

    FDA Recall
    Terminated ·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006

    Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)

    FDA Enforcement
    Class II ·Ongoing·Isopure Corp·July 20, 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