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

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    CuffLink Implant System Biocomposite

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-4

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 56

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 15, 2021

    STEM: AMISTEM H HA COATED STD STEM SIZE5

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 20, 2018

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 20, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 27, 2011

    INVACARE LYNX MICRO PORTABLE SCOOTER

    FDA Adverse Event
    *·Product code INI·September 30, 2008

    BD NEXIVA DIFFUSICS W/MAXZERO 24G X 0.75 IN

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 21, 2025

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 18, 2018

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·May 22, 2018

    BD NEXIVA DIFFUSICS W/MAXZERO 24G X 0.75 IN

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·March 24, 2025

    SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

    FDA Enforcement
    Class II ·Terminated·SenTec AG·August 14, 2019

    BD NEXIVA DIFFUSICS W/MAXZERO 24G X 0.75 IN

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 24, 2025