BEUDAMED
    15 results · 34ms · Sources: EU EUDAMED, US FDA

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    GOMCO SUCTION PUMP CABINET CHANGE

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

    ChM 4.5mm Cortical screws

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STERILE DRESSING PACK

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

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172972113·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971604·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971611·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172973585·

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172972106·

    JGRKNT 1.4MM SHRT NDLS 10PK

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code MBI·January 31, 2020

    JGRKNT 1.4MM SHRT NDLS 10PK

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code MBI·January 31, 2020

    BI-METRIC/X POR NC 13X145

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·January 7, 2020

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 15, 2014

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·June 1, 2015

    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