BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    CK REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ODFS Pace XL

    FDA 510(k)
    FDA Class 2 ·Neurology

    CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPIROPERFECT

    FDA Adverse Event
    Malfunction ·MEDIKRO OY·Product code BZG·August 11, 2023

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    JUMAO MEDICAL EQUIPMENT·Product code IOR·July 31, 2014

    ESSIX C+

    FDA Adverse Event
    Injury ·DENTSPLY RAINTREE ESSIX GLENROE·Product code MQC·January 12, 2011

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·November 20, 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