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

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    BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BILOX PROSTHESIS HEAD 12/14 28MM L

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

    OPUS ROD FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CEMENTED CALCAR HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIOLOX PROSTHESIS HEAD 12/14 28MM S

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

    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

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    MEDEL S.P.A.·Product code BTI·April 29, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·May 10, 2011

    UNKNOWN DEPUY INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 28, 2008

    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

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    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

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020