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

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    HQS INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIO-MODULAR SHOULDER SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304214002·

    7450 RV2 MASK

    FDA UDI
    HANS RUDOLPH, INC.·00817136021966·7450S W/1410A SM 2W NRBV & HG

    PRESTODR 4143

    FDA 510(k)
    FDA Class 2 ·Radiology

    TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    ASR UNI FEMORAL IMPL SIZE 53

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

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 24, 2014

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code DQX·June 3, 2011

    MONGOOSE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO.LTD.·Product code DQO·December 15, 2017

    BIO-MOD HUM HEAD 44DIAX17MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSD·January 17, 2020

    BIO-MOD ST.12X115 W/ALIGN HOLE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSD·January 17, 2020

    R3 XLPE INSERT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDI·May 25, 2025

    VERSA-DIAL SHOULDER SYSTEM MODULAR HEAD 46X18X53

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MBF·September 9, 2016

    BIO-MOD ST. 9X115 W/ALIGN HOLE W/ALN HOLE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·October 18, 2022

    BIO-MOD HUM HEAD 48DIAX24MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWT·June 29, 2021

    COMP PRIMARY STEM 7MM STD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·June 29, 2021

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Model Number L231, PROPONENT DR EL MRI Pacemaker

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