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

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    FDA 510(k)
    FDA Class 2 ·Radiology

    N/A

    FDA UDI
    MEDTRONIC XOMED, INC.·00763000034740·PROSTHESIS 1112096 CAM CAP FULL CANN

    NA

    FDA UDI
    MEDTRONIC XOMED, INC.·00681490033404·PROSTHESIS 1112096 CAM CAP FULL CANN

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756609982·Arm Sling

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08809282812699·

    Integrity-SI Fusion System

    FDA UDI
    Lincotek Medical LLC·B57112521112096D0·12 x 95 mm SI Implant Fully Threaded with HA Co...

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08809282815164·

    POWDER FREE NITRILE EXAMINATION GLOVES, BLUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DISPOSABLE VITRECTOMY LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    AED PRO

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·May 2, 2013

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code LTJ·June 2, 2011

    NEUROFORM 3 STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code NJE·August 6, 2008

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021