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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    TISSUE INTEGRATED PROSTHESIS DRILL

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    RHYTHMSTAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GE LOGIQ 7 ULTRASOUND BT04

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIT, DRILL

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code HTW·October 26, 2017

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 30, 2014

    10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HSB·November 21, 2012

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 22, 2010

    AIM-ARM 130° F/PFNA BLADE

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code FZX·September 29, 2014

    PKG, GRASPER FORCEPS, TISSUE, P/N 0250080284. 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