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

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    DTX Studio design

    FDA 510(k)
    FDA Class 2 ·Dental

    Vanguard Select Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304555617·

    SignaLoc Screw

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215116972·

    IGLUCOSE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ENDEARE BREAST PUMP

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 28, 2020

    LEAD MODEL UNKNOWN

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·June 21, 2013

    ACCU-CHEK MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·September 22, 2008

    PRC AC5000

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code LLZ·July 16, 2008

    BIOMET FINNED PRI STM 80X12.5

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·March 2, 2020

    E1 VNGD AS TIB BRG 11X79

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·March 2, 2020

    VIEWFLEX XTRA ICE CATHETER

    FDA Adverse Event
    Malfunction ·STERILMED, INC.·Product code OWQ·April 19, 2023

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020