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

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    AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    FORTRESS MODEL SPIRIT 4-WHEEL POWER WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DIOLASE

    FDA 510(k)
    FDA Class 1 ·Radiology

    (2BO)ALPHA I 20CM SCROTAL

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code FHW·July 24, 2018

    ENDOVIVE¿ SAFETY PEG KIT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SPENCER·Product code KNT·January 14, 2013

    INTEGRATED APD SET W/CASSETTE3-PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 3, 2010

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 4, 2014

    PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080361. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 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