BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    LaseMD LEO Laser System

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

    LDR SPINE USA SPINETUNE TL SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110;

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code CAW·October 22, 2014

    CROSSER

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC. ,·Product code DQY·June 26, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014