BEUDAMED
    15 results · 23ms · Sources: EU EUDAMED, US FDA

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    Luna Dental Implant System- Healing Abutment

    FDA 510(k)
    FDA Class 2 ·Dental

    Vilex Jones Fracture Guidewire

    FDA UDI
    VILEX LLC·00841731123558·Wire, Guide 1.8x200mm Sgl Trocar

    Vilex Jones Fracture Guidewire

    FDA UDI
    VILEX LLC·00841731123084·Wire, Guide 1.8x200mm Sgl Trocar

    PIERSE FIXATION FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896094031·PIERSE FIXATION FORCEPS ROUND HANDLE LIGHT WEIGHT

    Initia Total Hip System

    FDA UDI
    KYOCERA CORPORATION·04547898306891·MX LINER 40-56/58

    PQ1

    FDA 510(k)
    FDA Class 2 ·Dental

    EXEL BUTTERFLY SCALP VEIN SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STOCKERT 70 RF GENERATOR

    FDA Adverse Event
    Injury ·STOCKERT GMBH·Product code DRF·August 10, 2011

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Other ·BECKMAN COULTER, INC.·Product code JJE·September 24, 2008

    UNK

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·July 1, 2013

    EVOLUT FX PLUS VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025

    SMR SHOULDER

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code PHX·October 15, 2024

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    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