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

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    INTEGRA PROXIMAL HUMERAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010064844·4.0MM PARTIALLY THREADED ...

    Z Liquid HT D3-C 100ml

    FDA UDI
    ARGEN CORPORATION, THE·D818121826·Dental porcelain/ceramic restoration kit

    HYDROFIX VASO SHIELD, MODEL HVS-001-0610

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TARGETING ARM PROX. LAT. TIBIA LEFT

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·February 2, 2012

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·November 17, 2016

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code NDN·March 28, 2013

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code NDN·February 27, 2013

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code NDN·March 1, 2013

    VERTECEM V+ CEMENT KIT

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NDN·February 27, 2013

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHA·May 20, 2011

    ACRYSOF IQ TORIC

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·May 15, 2013

    ENDURANT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·September 26, 2014

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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