BEUDAMED
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    DESS Dental Smart Solutions

    FDA 510(k)
    FDA Class 2 ·Dental

    Bernafon

    FDA UDI
    Bernafon AG·05711584087060·ZR3, KIT 10 75 BE ZERENA 3

    ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM

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

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 10, 2025

    CONTOUR® XT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 23, 2026

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 27, 2013

    XPRT MATTRESS WITH PENDANT

    FDA Adverse Event
    Other ·STRYKER CORP DBA GAYMAR·Product code FNM·July 29, 2011

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 1, 2026

    CONTOUR® XT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 31, 2025

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 12, 2026

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 11, 2025

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·October 8, 2025

    SUBDURAL ELECTRODE

    FDA Adverse Event
    Malfunction ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GYC·August 18, 2025

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023

    CONTOUR® PLUS

    FDA Adverse Event
    Injury ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 4, 2025

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012