BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIMENSION EXL 200

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·July 23, 2013

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471150690·K-WIRE - SINGLE TROCAR 0.9mm DIA x 75mm

    JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR

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

    BUCCAL TUBE, BUCCAL ATTACHMENT

    FDA 510(k)
    FDA Class 1 ·Dental

    FUSION QUATTRO EXTRACTION BALLOON

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC.·Product code GCA·May 1, 2014

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·February 1, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·December 29, 2010

    PKG, 5MM INSERT, TENACULUM, 33CM, P/N 0250080698 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