BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD

    FDA 510(k)
    FDA Class 2 ·Radiology

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857581494·Split Tube Retractor Ø26x60 mm

    MAMMAPRINT

    FDA 510(k)
    FDA Class 2 ·Immunology

    KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·November 7, 2019

    INTERJECT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FCG·May 27, 2025

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·October 4, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    ASR 300 SIZE 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·June 22, 2011

    TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.

    FDA Enforcement
    Class II ·Terminated·Cardiac Assist, Inc·February 19, 2020

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017