BEUDAMED
    17 results · 26ms · Sources: EU EUDAMED, US FDA

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    PIEZOMED

    FDA 510(k)
    FDA Class 2 ·Dental

    AGXO

    FDA UDI
    Oticon A/S·05707131261830·H100, BTE 13 WL 85 DBL AGXO

    CMI MAGNETOCARDIOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONCORDE BULLET CAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 120

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·January 8, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 29, 2013

    UNKNOWN ZIMMER ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JWH·June 15, 2011

    GEMINI STONE RETRIEVAL PAIRED WIRE / HELICAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FFL·August 22, 2008

    COOK® MULTI-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·May 10, 2019

    COOK SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·February 21, 2020

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·August 19, 2019

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·October 15, 2019

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·December 10, 2019

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Injury ·COOK INC·Product code GEX·November 4, 2022

    COOK SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·March 3, 2020

    COOK SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·February 13, 2020

    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