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

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    CLINCAL HAND MASTER SYSTEM MODEL # EXH9000-002

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LARGE AO COUPLING ASNIS III HALL FITTING

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 25, 2012

    IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    M2A-MAGNUM PF CUP 58ODX52ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·April 27, 2026

    M2A-MAGNUM MOD HD SZ 52MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·April 27, 2026

    COBAS C 503 ANALYTICAL UNIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·May 26, 2026

    SPRINT

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code LWS·December 13, 2010

    TRIMA ACCEL

    FDA Adverse Event
    TERUMO BCT·Product code GKT·January 18, 2013

    MONOCRYL PLUS SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAM·July 9, 2014

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021