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

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    BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    S2 TIBIAL NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIPIVIEW OCULAR SURFACE INTERFEROMETER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    AUTOSOFT XC

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

    AUTOSOFT XC

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

    AUTOSOFT XC

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

    BARDIA FOLEY CATHETER SILICONE COATED K922431

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON) -1018233·Product code KOD·November 1, 2021

    ARTICULEZE M HEAD 36MM +8.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDIC INC, 1818910·Product code JDI·January 18, 2013

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 5, 2014

    ev3 Pipeline Flex Embolization Device. For neurological endovascular use.

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020

    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