BEUDAMED
    10 results · 28ms · Sources: EU EUDAMED, US FDA

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    VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM

    FDA 510(k)
    FDA Class 2 ·Neurology

    Monkey Rings™ External Fixation System

    FDA UDI
    Paragon 28, Inc.·00889795115294·Schanze Screw, Self Drilling, Ø4.0mm x 34mm, 12...

    HEXIDIS ALCOHOL SWAB

    FDA 510(k)
    FDA Unclassified ·Unknown

    DANNIFLEX MODEL 500TM CPM

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 3, 2010

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·January 14, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 4, 2014

    PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code HSX·October 15, 2025

    GENESIS UNI KNEE FEMORAL COMPONENT COCR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code HSX·May 23, 2025

    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