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

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    GEM Flow COUPLER Device and System

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

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·February 20, 2020

    NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 6, 2014

    PK DISSECTING FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 3, 2013

    BABY CONTROL COSYCOT INFANT WARMER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code FMT·June 29, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·July 28, 2019

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·March 22, 2020

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NKB·October 18, 2017

    Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·July 2, 2014