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

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    AMIZYME-HSV TYPES 1 & 2 TEST KITS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Endodontic Hand Instruments

    FDA UDI
    TULSA DENTAL PRODUCTS LLC·D71668425311·Ready•Steel K-FILE 025 31MM

    EasyTouch

    FDA UDI
    MHC MEDICAL PRODUCTS, LLC·MHC18425311·

    UPDATED SLIP UROLOGY INTRODUCER SHEATH

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    F1-Modular Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 21, 2014

    ASR UNI FEMORAL IMPL SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·November 21, 2012

    ASR ACETABULAR CUPS 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·September 17, 2010

    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