BEUDAMED
    17 results · 20ms · 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.

    SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074549798·DISTRACTOR/TRIAL 2982236 12 X 36MM L

    READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CIRCUITGUARD CIRCUITGUARD HME

    FDA Adverse Event
    Other ·ARC MEDICAL INC., ANESTHESIA & RESPIRATORY CARE·Product code BYD·July 20, 2005

    CADD LEGACY PLUS PUMP

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·January 20, 2025

    BD MULTI-CHECK CD4 LOW CONTROL

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 29, 2023

    CADD LEGACY PLUS PUMP

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FRN·September 9, 2022

    BD MULTI-CHECK¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 5, 2023

    BD MULTI-CHECK¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 22, 2023

    BD MULTI-CHECK¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 22, 2023

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·January 25, 2013

    TRIATHLON CR X3 TIBIAL INSERT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·January 24, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014

    BD MULTI-CHECK¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 26, 2023

    BD MULTI-CHECK CD4 LOW CONTROL

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 16, 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