BEUDAMED
    16 results · 27ms · Sources: EU EUDAMED, US FDA

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    PHILIPS MODEL MX 16 SLICE CT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·October 23, 2013

    BILOX PROSTHESIS HEAD 12/14 28MM L

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·May 23, 2014

    FRESENIUS OPTIFLUX 200A

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

    CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BIOLOX PROSTHESIS HEAD 12/14 28MM S

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 27, 2012

    GRAFTYS HBS (510K NUMBER: K082498)

    FDA Adverse Event
    Injury ·GRAFTYS·Product code MQV·July 11, 2013

    BIOLOX PROSTHESIS HEAD 12/14 28MM S

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 14, 2014

    BIOLOX PROSTHESIS HEAD 12/14 28MM M

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 27, 2012

    BIOLOX PROSTHESIS HEAD 12/14 32MM L

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014

    BIOLOX PROSTHESIS HEAD 12/14 28MM S

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·April 29, 2013

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC./ MEDOSA S.A.·Product code JXG·July 29, 2008

    MAXCEM ELITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·May 10, 2011

    ECHELON ENDOPATH

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 2, 2026

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014