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

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    TUBE GRIP

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123854·K-WIRE - DOUBLE TROCAR 2.0mm DIA x 100mm

    AUTOSOFTÂ XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 26, 2024

    ACTIBAND

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 18, 2013

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·February 6, 2014

    CONSULTA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NIK·December 13, 2010

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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