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

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    ULTIMA FIVE

    FDA 510(k)
    FDA Class 2 ·Neurology

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B582083494·AWL

    BILOX PROSTHESIS HEAD 12/14 28MM L

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

    MIMIX BONE REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    3.75MM AND 5.0MM SPLINE TWIST IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    BIOLOX PROSTHESIS HEAD 12/14 28MM S

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

    OXF PH3 CEMENTLESS FEM SZ XSM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·June 8, 2022

    OXFORD PKS ANATOMIC ARCOM MENISCAL BRG - XSMALL RIGHT SIZE 4

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·June 8, 2022

    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

    MAXCEM ELITE

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

    PINN MAR +4 10D 36IDX54OD

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

    IMPL TWIST MTX 3.75 MM 10 MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 17, 2024

    OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·June 26, 2024

    Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the 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. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 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