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

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    TOXO IGG ELISA TEST (MODIFIED)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PVC VINYL GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK

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

    UNIFY CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 15, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 6, 2010

    AUTOPULSE LI-ION BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC·Product code DRM·December 6, 2012

    PKG, BIPOLAR FORCEPS, PADDLE, 45CM, P/N 0250080351. 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