BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    ELECTROSCOPE MONITOR, EM-1

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

    REVELATION DIAMOND

    FDA UDI
    Ss White Burs, Inc.·D6909136252·REVELATION DIAMOND 878K-014C - 5 PACK

    DSS STABILIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PERMACOL

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

    RESTYLANE INJECTABLE GEL

    FDA Adverse Event
    Other ·Q-MED AB·Product code LMH·January 8, 2013

    RECONSTITUTION DEVICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·December 3, 2010

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    KENTSTONE·Product code ITJ·July 3, 2014

    PKG, SPRING HANDLE, P/N 0250080237. 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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015