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

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    Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants

    FDA 510(k)
    FDA Class 2 ·Dental

    NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM

    FDA 510(k)
    FDA Class 2 ·Dental

    ADVOCATE REDI-COD DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 23, 2025

    STARDRIVE SCREWDRIVER SHAFT T4/42MM/SELF-RETAINING

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HXX·March 12, 2014

    QUICKFLEX MICRO LV LEAD

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code NIK·January 13, 2014

    DBS SINGLE EXTENSION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 25, 2013

    OT VERIO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 5, 2011

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·December 10, 2024

    STARDRIVE SCREWDRIVER SHAFT W/HOLDING SLEEVE/T4/66MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HXX·March 12, 2014

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·January 5, 2023

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·July 1, 2015