BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS

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

    NA

    FDA UDI
    Richard Wolf GmbH·04055207023259·OBTURATOR FOR NEPHROSCOPE 20.8FR WL 230 mm, ro...

    VIALON OBTURATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PHARMACOKINETICS SOFTWARE SYSTEM (PPS)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·February 15, 2013

    ADVANCE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·December 21, 2010

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DRE·July 11, 2014

    BIPOLAR HIP

    FDA Adverse Event
    Injury ·ENCORE MEDICAL, L.P.·Product code KWY·October 6, 2014

    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