BEUDAMED
    14 results · 30ms · Sources: EU EUDAMED, US FDA

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    Lipogems System

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

    Stainless Steel Femoral Nailing System

    FDA UDI
    ORTHOFIX SRL·18032568033755·FLEXIBLE REAMER D 13.5 MM

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694045636·PrimaLIF LLIF PEEK Implant, 11mm X 26mm X 35mm,...

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE,BLUE, PINK)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DEPUY CI HIP INSTRUMENTATION

    FDA 510(k)
    FDA Class 2 ·Neurology

    UNSPECIFIED BD INTIMA-II¿ Y 24GAX0.75IN PRN/EC SLM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·March 20, 2019

    BD INTIMA-II 18GAX1.16IN PRN SLM NPVC

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·April 8, 2025

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 14, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·June 30, 2011

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·September 18, 2008

    INTIMA-II Y 20GAX1.16IN PRN/EC SLM

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code FOZ·August 17, 2020

    BD INTIMA II

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·March 28, 2025

    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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

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