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

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    WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PE anti-human CD38

    FDA UDI
    BIOLEGEND, INC.·00810034700476·URL: https://www.biolegend.com/en-us/products/p...

    Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CAYMAN BUTTRESS PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 25, 2014

    2520274-2013-10709

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code MNI·February 22, 2013

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 7, 2011

    Actical with Step, Part Number 198-0302-00, Mini Mitter, a Respironics Company, Bend, Oregon

    FDA Recall
    Terminated ·Mini-Mitter Company, Inc.·Product code M·June 27, 2007

    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