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

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    DIANA FUSION CAGE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16710911220·

    Conmed/Linvatec

    FDA UDI
    Provision·B504OM50911220·

    Conmed/Linvatec

    FDA UDI
    Provision·00810041066176·

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048438003671·Morcellator Knife

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450210680·

    NA

    FDA UDI
    STERILMED, INC.·10888551021081·BUR ROUND MEDIUM

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450223222·

    BALLPEN SPINAL NEEDLE W/WO INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH

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

    ACCUTORR V MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014

    HIRES 90K

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS, LLC.·Product code MCM·May 6, 2011

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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