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

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    SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PAGEWRITER TC 20 CARDIOGRAPH

    FDA Adverse Event
    Malfunction ·PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC·Product code DPS·May 17, 2021

    BREAS VIVO 60

    FDA Adverse Event
    Malfunction ·BREAS MEDICAL AB·Product code NOU·July 31, 2017

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·October 1, 2014

    ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (CE)·Product code IYO·May 29, 2013

    HIRES 90K

    FDA Adverse Event
    Injury ·ADVANCED BIONICS LLC·Product code MCM·August 22, 2008

    BREAS VIVO 60

    FDA Adverse Event
    Malfunction ·BREAS MEDICAL AB·Product code NOU·September 15, 2015

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 16, 2024

    BREAS VIVO 60

    FDA Adverse Event
    Malfunction ·BREAS MEDICAL AB·Product code NOU·May 12, 2017

    BREAS VIVO 60

    FDA Adverse Event
    Malfunction ·BREAS MEDICAL AB·Product code NOU·May 12, 2017

    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