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

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    Straumann Bone Level NC Angled Screw Retained Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    TRUSIGNAL SPO2 FINGERTIP SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTERLAB MICROCAL SERUM CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ENLITE

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·October 4, 2014

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 28, 2013

    ADAPTA SR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NVZ·June 28, 2011

    PKG, 5MM INSERT, RETENTION GRASPER, 33CM, P/N 0250080697 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

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014