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

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    Heel Stick Safety Lancet (HHZ-II, HHZ-III)

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

    VEO® Lateral Interbody Fusion System

    FDA UDI
    Choice Spine, LP·00840996134200·LATERAL,COBB DISSECTOR,STRAIGHT

    DR GREENBURGS HYBRID VACUUM

    FDA 510(k)
    FDA Class 2 ·Dental

    Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 30, 2024

    GLIDEWELL HT IMPLANT Ø3.5 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 25, 2024

    GLIDEWELL HT IMPLANT Ø3.5 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 24, 2025

    GLIDEWELL HT IMPLANT Ø3.5 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 5, 2025

    GLIDEWELL HT IMPLANT Ø3.5 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT·Product code DZE·July 17, 2025

    GLIDEWELL HT IMPLANT Ø3.5 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 25, 2024

    GLIDEWELL HT IMPLANT Ø3.5 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 8, 2024

    GLIDEWELL HT IMPLANT Ø3.5 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·December 30, 2024

    CONSEPT 1NEUTRALIZING TABLET

    FDA Adverse Event
    Malfunction ·ADVANCED MEDICAL OPTICS, INC.·Product code LPN·October 31, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011

    UNIFY ASSURA CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025