BEUDAMED
    13 results · 24ms · Sources: EU EUDAMED, US FDA

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    DEPUY PULSE THORACOLUMBAR SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALPHA DRIVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·October 2, 2020

    NEXGEN PROVISIONAL ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HWT·February 26, 2020

    UNKNOWN DEPUY ASR ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 15, 2013

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

    SELF CENT HIP 47X28 BRN

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·May 20, 2011

    VANGUARD MONO FINNED STM TIB 71X14

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JWH·December 9, 2024

    VANGUARD ROCC TIB BRG UHMWPE 60X10MM

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JWH·September 16, 2025

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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