BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    FENNING FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Eye Shield

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111154·FOX EYE SHIELD GARTER ASST COLOR PK/50

    VANGUARD COMPLETE KNEE CRUCIATE RETAINING POROUS & HA FEMUR LEFT 75MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MBH·December 16, 2016

    VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Reprocessed Polaris X Steerable Diagnostic EP Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SOFPORT ADVANCED OPTIC LENS

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code HQL·February 8, 2013

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 15, 2014

    SYBRONPRO STRAIGHT ABUTMENT

    FDA Adverse Event
    Injury ·EBI INC.·Product code NHA·January 13, 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