BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    Livewire Electrophysiology Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Masel

    FDA UDI
    Ortho Organizers, Inc.·00190707040895·Choice™ Distal End Cutter w/ Safety Hold

    ProLift

    FDA UDI
    Life Spine, Inc.·00190837105822·Static Expandable Cage Trial, 12mm x 28mm x 12m...

    FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL

    FDA 510(k)
    FDA Class 2 ·Dental

    NOVABONE PUTTY - RESORBABLE BONE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·August 22, 2018

    ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 8, 2014

    SUPER ARROW-FLEX

    FDA Adverse Event
    Malfunction ·TELEFLEX INCORPORATED·Product code DYB·April 16, 2013

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·June 29, 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