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

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    LIFECELL TISSUE EXPANDER

    FDA 510(k)
    FDA Unclassified ·Unknown

    APEX™

    FDA UDI
    B. BRAUN MEDICAL INC.·04046964539268·EVA Dual-Chamber Final Containers 1500 mL

    HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AZE VIRTUALPLACE-MR FLOW ANALYSIS SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 14, 2013

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 25, 2011

    LIFEPAK 20E DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·August 11, 2008

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 23, 2025

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 23, 2025

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 22, 2025

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPU·December 23, 2025

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 22, 2025

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 23, 2025

    WALLFLEX? BILIARY TRANSHEPATIC

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code FGE·August 21, 2012

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

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

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

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