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

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    HYGROBAC,S HYGROBOY AND HYGROBABY

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471150751·K-WIRE - SINGLE TROCAR 1.25mm DIA x 200mm

    DURADIAGNOST

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    ACL ADVANCE

    FDA Adverse Event
    INSTRUMENTATION LABORATORY CO.·Product code JPA·July 13, 2005

    Z-LOOK3

    FDA Adverse Event
    Injury ·Z-SYSTEMS AG·Product code DZE·February 4, 2013

    COBAS 6000 E601 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code MMI·December 29, 2010

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code MGB·July 17, 2014

    PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 29CM, P/N 0250282101 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