BEUDAMED
    19 results · 20ms · Sources: EU EUDAMED, US FDA

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    SYNGO VIA MI WORKFLOWS

    FDA 510(k)
    FDA Class 2 ·Radiology

    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

    8940 MASK

    FDA UDI
    HANS RUDOLPH, INC.·00817136020600·8940 ADULT SM MASK W/2630 2W

    MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 - LATER

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code HSX·December 16, 2020

    OneStep

    FDA UDI
    Diagnostic Automation, Inc.·10894175000081·OneStep hCG Combo Urine/Serum RapiCard™ InstaTe...

    QMedix™

    FDA UDI
    Diagnostic Automation, Inc.·00850054026651·QMedix™ hCG Combo Urine/Serum RapiCard™ InstaTe...

    SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONSERVE BIO FOAM SHELL

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 LM - 8MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code HSX·October 26, 2023

    EON

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013

    QUATTRODE

    FDA Adverse Event
    Injury ·ST JUDE MED - NEUROMODULATION·Product code GZB·September 17, 2014

    LIGASURE ATLAS HANDSWITCHING 37CM

    FDA Adverse Event
    Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·May 25, 2011

    UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·July 8, 2024

    UNK - RODS: EXPEDIUM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·July 8, 2024

    SmartPath to dStream for 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025