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

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    SUTURE STRIP

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DELTA-A.V. FISTULA CANNULATION SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EMIT-STM ETHYL ALCOHOL ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MICRO RECIPROCATING SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·June 2, 2014

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·November 21, 2012

    ACCURUS 800CS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·September 1, 2010

    PKG, FUNDUS FORCEPS, P/N 0250080315. 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