BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO GAMMA GUIDANCE SYSTEM

    FDA 510(k)
    FDA Class 1 ·Radiology

    VAS-CATH CATHETER REPAIR KIT

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

    MODIFIED PK300 AUTOMATIC EIA ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TOTAL ASR FEM IMP SIZE 53

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·February 28, 2013

    DEPTH GAUGE FOR SCREWS: 2.7/3.5/4.0MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS SELZACH·Product code HWC·January 20, 2011

    2 MM COARSE DIAMOND BALL, STD

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·December 18, 2013

    BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HWC·June 3, 2016

    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