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

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    Sentimag System, Sentimark Magnetic Marker Systerm

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

    McKesson

    FDA UDI
    MCKESSON MEDICAL-SURGICAL INC.·10612479141244·Hydrogel Impregnated Gauze

    Ni-Lock® Anterior Cervical Plate System

    FDA UDI
    Spine Wave, Inc.·10840642103052·Plate 44mm 3 Level

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100127·KRATZ-BARRAQUER SPECULUM RIGHT EYE

    BD LUER-LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 20, 2022

    AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LOCKING CAP

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code KTT·October 19, 2012

    LOCKING CAP

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code KTT·October 19, 2012

    LOCKING CAP

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code KTT·October 19, 2012

    LOCKING CAP

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code KTT·October 19, 2012

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DXY·June 8, 2013

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCO·Product code CBK·June 17, 2011

    ARTICUL/EZE BALL 28 +5 BR

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code JDI·September 5, 2008

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·December 12, 2017

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·December 27, 2016

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·March 10, 2017

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·March 10, 2017

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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