BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    AOS Anterolateral Proximal Humeral Plate

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Argyle

    FDA UDI
    Cardinal Health 200, LLC·10192253040203·Umbilical Vessel Catheter Insertion Tray

    Argyle

    FDA UDI
    Cardinal Health, Inc.·10884527005086·Umbilical Vessel Catheter Insertion Tray,No Cat...

    BONASTENT® Tracheal/Bronchial

    FDA UDI
    Sewoon Medical Co., Ltd.·08806369468862·

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383535687·Gutta Percha Points is used to root canal filin...

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193024169·B-P MODULAR EXTENSION W/ULTRACOAT - 9 MM X 100 MM

    POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEMOHALT HEMOSTASIS PAD

    FDA 510(k)
    FDA Unclassified ·Unknown

    PENUMBRA MAX PUMP - INDIGO SYSTEM

    FDA Adverse Event
    Malfunction ·PENUMBRA INC., USA·Product code NRY·August 23, 2018

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·March 8, 2018

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 220

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·April 9, 2018

    ADAPTA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 10, 2013

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 20, 2011

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 3, 2016

    Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For atomization of topical solutions across the naso and oropharyngeal mucosal membranes

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 28, 2016

    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