BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    TENS

    FDA 510(k)
    FDA Class 2 ·Neurology

    BELIFU

    FDA Adverse Event
    Injury ·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020

    CORLINK AUTOMATED ANASTOMOTIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    QUATTRO AIR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OT ULTRALINK METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 2, 2014

    AEQUALIS

    FDA Adverse Event
    Injury ·TORNIER SAS·Product code KWS·May 23, 2013

    SAGB QUICK CLOSE

    FDA Adverse Event
    Injury ·OBTECH MEDICAL SARL_·Product code LTI·June 20, 2011

    THORATEC® HEARTMATE® XVE AND HEARTMATE II®, APICAL CORING KNIFE

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·October 19, 2023

    FUJIFILM

    FDA Adverse Event
    Death ·FUJIFILM TECHNO PRODUCTS CO., LTD. MITO SITE·Product code FDF·July 22, 2016

    FUJIFILM

    FDA Adverse Event
    Death ·FUJIFILM TECHNO PRODUCTS CO., LTD.·Product code FCX·July 22, 2016

    FUJIFILM

    FDA Adverse Event
    Death ·FUJIFILM TECHNO PRODUCTS CO., LTD. MITO SITE·Product code FDS·July 22, 2016

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015