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

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    ICE ZIRKON TRANSLUZENT

    FDA 510(k)
    FDA Class 2 ·Dental

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741322300·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674132230060·

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613024192·Metzenbaum Scissors, TC, Curved, Fine, Blunt Ti...

    COMPREHENSIVE LOCKING SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWC·July 5, 2019

    NUGARD NITILE GREY COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    RHYTHM DIGITAL ELECTRONIC STETHOSCOPE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 27, 2021

    FUJIFILM 600 SERIES ENDOSCOPE EC-600WM

    FDA Adverse Event
    Malfunction ·FUJIFILM CORPORATION·Product code FDF·January 22, 2025

    OXF ANAT BRG RT MD SIZE 3 PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·November 1, 2018

    OXF TWIN-PEG CMNTD FEM MD PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·November 1, 2018

    VITALITY

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 1, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·June 14, 2011

    Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·October 3, 2018

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 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

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015