BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    GPS Spacers

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 16, 2024

    INTRAORAL BELSENSOR GOLD

    FDA 510(k)
    FDA Class 2 ·Dental

    Lysus Infusion System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2025

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·February 4, 2016

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·December 1, 2015

    DILAPAN-S

    FDA Adverse Event
    Other ·MEDICEM TECHNOLOGY S.R.C.·Product code LOB·April 23, 2013

    PHILIPS INFORMATION CENTER

    FDA Adverse Event
    Death ·PHILIPS HEALTHCARE - ANDOVER·Product code MHX·June 21, 2011

    ANSPACH® XMAX

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code ERL·October 5, 2014

    PKG, 3MM INSERT, MARYLAND, FORCEPS CURVED, 29CM, P/N 0250282058 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