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

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    CASPIAN OCT SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517565365·CoRoent Ant TLIF PEEK, 13x13x28mm 8°

    DEKA SYNCHRO FT

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

    VPAP ST-A

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 20, 2013

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 20, 2011

    PUMP MMT-715RNAP PRDGM INS PL EN ML PR

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·August 21, 2008

    COOK® MULTI-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·May 10, 2019

    HEMOCONCENTRATOR BC 20 PLUS

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code KDI·April 1, 2016

    COOK SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·February 21, 2020

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·August 19, 2019

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·October 15, 2019

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·December 10, 2019

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Injury ·COOK INC·Product code GEX·November 4, 2022

    COOK SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·March 3, 2020

    COOK SINGLE-USE HOLMIUM LASER FIBER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·February 13, 2020

    UNK HIP FEMORAL STEM CORAIL

    FDA Adverse Event
    Death ·DEPUY IRELAND - 9616671·Product code LZO·June 7, 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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015