BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    DEKA LipoAI

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEKA LIPOAI

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 4, 2025

    NuVasive

    FDA UDI
    Nuvasive, Inc.·00195377046833·NTS Slot Tube, 22x70mm Beveled

    DOA Kit, 5D US Plus

    FDA UDI
    Align Technology, Inc.·00816063021094·DOA Kits

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 10, 2023

    STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014

    CONCERTO II CRT-D

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NIK·August 15, 2011

    OT PING ENHANCED METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013

    ACCUTREND CHOLESTEROL

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CHH·May 25, 2018

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023