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

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    SureLead Cable System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Immunology

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 20, 2013

    CONVERTBL I.V. DUAL CHANNEL HSP

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·July 7, 2011

    GEMSTAR 7 THERAPY PUMP

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·September 29, 2008

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+3MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·December 13, 2021

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0°

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·July 5, 2023

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·November 24, 2022

    SHOULDER SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PHX·December 2, 2024

    ANATOMIC SHOULDER PROSTHESIS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWS·May 23, 2025

    REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·January 12, 2022

    SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - 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

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36X27

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·June 25, 2021

    ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID 48

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWS·September 21, 2021

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+0MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·November 24, 2022

    SHOULDER SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PHX·November 13, 2024

    SHOULDER SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PHX·November 18, 2024

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·February 20, 2025

    ANATOMIC SHOULDER PROSTHESIS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWS·April 23, 2026