BEUDAMED
    9 results · 31ms · Sources: EU EUDAMED, US FDA

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    HOTDOG MULTI FUNCTION CONTROLLER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WISP

    FDA UDI
    Respironics, Inc.·00606959012912·Wisp Mask, Fabric Frame, without headgear, USA

    SALTER LABS MODIFIED NEBUTECH NEBULIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SURESET 3.0 ML RESERVOIR, MODEL 24-103

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ASR UNI FEMORAL IMPL SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 6, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·September 16, 2014

    COBLATOR II SYSTEM

    FDA Adverse Event
    Other ·ARTHROCARE CORP.·Product code GEI·April 29, 2011

    Zeiss brand IOLMaster 500, Model 500, 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

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for 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.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015