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

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    OMEGA+ COMPRESSION SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867062436·UNIVERS REVERS TRIAL SPACER 42+6MM

    MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN

    FDA 510(k)
    FDA Class 1 ·Microbiology

    THE KAUFMANN LIFT-AND-TURN MATTRESS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    REVEAL XT

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DSI·February 11, 2013

    TRANSFER SET MINICAP INTEGRALTWIST CLAMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·January 10, 2011

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·December 13, 2013

    STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - CORK·Product code DTK·May 14, 2013

    23GA ILLUMINATED DIRECTIONAL LASER PROBE

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQB·March 19, 2020

    25GA ILLUMINATED DIRECTIONAL LASER PROBE

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQB·March 19, 2020

    Zeiss brand IOLMaster, Version 1-5, 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