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

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    MIPLNI YK-244 Disposable Surgical Mask

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

    PEDICLE SCREW 03.58.225 MUST MC SCREW Ø5X45 CANNULATED

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·November 22, 2023

    FLEXIBLE CARDIAC COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIPOLAR PENCIL, MODEL 3901-002, 3900-002

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

    M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·April 9, 2026

    M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·November 18, 2025

    M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·July 11, 2025

    MYSPINE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·September 27, 2024

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 19, 2024

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 16, 2025

    MEDLINE UNITE

    FDA Adverse Event
    Injury ·MEDLINE INDUSTRIES, LP·Product code JDR·December 23, 2025

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 5, 2025

    CONTOUR® NEXT

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

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 2, 2025

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 29, 2014

    DEPUY ASR XL FEM IMP SIZE 57

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 9, 2011

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 8, 2013

    PEDICLE SCREW MUST MC SCREW Ø6X45

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKB·December 21, 2022

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012