BEUDAMED
    15 results · 24ms · Sources: EU EUDAMED, US FDA

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    Power Wheelchair (D10, D12, D15, D17, D20, D37)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    LCP

    FDA UDI
    Synthes GmbH·10886982168467·LCP® VOLAR DISTAL RADIUS PLATE EXTRA-ARTICULAR ...

    IVENT 201 PORTABLE VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 9, 2023

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code CAW·November 11, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 10, 2011

    ION?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 23, 2013

    CERENOVUS ENTERPRISE

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·December 5, 2025

    CERENOVUS ENTERPRISE

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·December 5, 2025

    PROWLER SELECT

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code QJP·December 5, 2025

    PROWLER SELECT

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code QJP·December 5, 2025

    CERENOVUS ENTERPRISE

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·December 5, 2025

    PKG, 5MM PEEK MONOPOLAR HANDLE, P/N 0250080617 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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024