BEUDAMED
    14 results · 29ms · Sources: EU EUDAMED, US FDA

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    IPS e.max One

    FDA 510(k)
    FDA Class 2 ·Dental

    Curved Plate

    FDA UDI
    I.T.S. GmbH·09120034309595·Curved Plate, 6-Hole, PRS RX System

    LEVEL ONE CMF

    FDA Adverse Event
    Injury ·KLS-MARTIN L.P.·Product code JEY·April 17, 2026

    SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INSPIRE OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·March 4, 2026

    INSPIRE OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·November 20, 2025

    CONTOUR TEST STRIPS (50)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·October 20, 2008

    TERUMO CDI 540 CALIBRATOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·August 10, 2011

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVACARE CLEVELAND STREET·Product code FSA·July 8, 2013

    ONDA PRO

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code PBX·February 4, 2026

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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