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

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    DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471150720·K-WIRE - SINGLE TROCAR 1.1mm DIA x 100mm

    TENS DEVICE FOR RELIEF OF CHRONIC PAIN

    FDA 510(k)
    FDA Class 2 ·Neurology

    ANATECH X-RAY GENERATOR

    FDA 510(k)
    FDA Class 1 ·Radiology

    PLM A+ SPANISH DEVIC

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 5, 2014

    GRAFTON DBM PUTTY

    FDA Adverse Event
    Injury ·OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC)·Product code NUN·February 15, 2013

    UNIVERSAL FLAT PANEL YOKE, LANDSCAPE

    FDA Adverse Event
    Malfunction ·STRYKER COMMUNICATIONS·Product code BRY·December 21, 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