BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    LUBINUS SP II HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FORCEPS CEV405 FENESTRATED 350MM JOHANN [MXI/XOM]

    FDA Adverse Event
    Injury ·XOMED MICROFRANCE MFG·Product code GEI·March 19, 2014

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X80MM X 125

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 17, 2012

    DICOM Viewer

    FDA 510(k)
    FDA Class 2 ·Radiology

    FIDIS CONNECTIVE 10, MODEL MX006

    FDA 510(k)
    FDA Class 2 ·Immunology

    HALO XP ELECTROPHYSIOLOGY CATHETER WITH AUTO ID

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·June 13, 2012

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·February 9, 2013

    SYNERGETIC 23G CHANDELIER

    FDA Adverse Event
    Injury ·SYNERGETIC·Product code FSY·January 4, 2011

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 23, 2014

    SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    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