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

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    Legend Pro DMA

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694006972·Screw System Organizer Block

    MAYO SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896055360·MAYO SCISSORS CURVED BEVELED TUNGSTEN CARBIDE B...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180102774·BIPOLAR RF-CABLE WITH AESCUULAP / DAVOL / MARIN...

    SENTRY EXPANDING INTRODUCER SHEATH (EIS)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SLEEPRIGHT

    FDA 510(k)
    FDA Unclassified ·Unknown

    BD LOGIC BLOOD GLUCOSE MONITOR

    FDA Adverse Event
    Other ·BECTON DICKINSON·Product code NBW·December 22, 2004

    BD¿ INSULIN PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·March 21, 2018

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAS

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 17, 2014

    ATTAIN OVER THE WIRE LEAD

    FDA Adverse Event
    Injury ·MPRI·Product code LWP·August 11, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 1, 2013

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code NIU·November 24, 2014

    ROD,FIXATION,INTRAMEDULLARY

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·October 3, 2018

    ROD,FIXATION,INTRAMEDULLARY

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·October 3, 2018

    ROD,FIXATION,INTRAMEDULLARY

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·October 3, 2018

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021