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

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    OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Best Medical International

    FDA UDI
    BEST MEDICAL INTERNATIONAL, INC.·00841365107917·

    ZEOS

    FDA UDI
    SANTA BARBARA IMAGING SYSTEMS, INC.·00812231031230·ARTHROSCOPE, 1.9MM 30DEG

    MEMOMETAL NAVIS BONE PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VARILITE LASER SYSTEM

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

    OSS LOCKING PIN

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code JDI·January 18, 2018

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011

    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