BEUDAMED
    17 results · 26ms · Sources: EU EUDAMED, US FDA

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    THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION

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

    FORZA

    FDA UDI
    Orthofix US LLC·18257200077984·ROTATING CUTTER - 7MM

    MICROTEC BACTERIAL FILTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CryoLab

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JCF·June 6, 2018

    BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JCF·June 7, 2018

    BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JCF·June 6, 2018

    BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JCF·April 27, 2018

    BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JCF·April 16, 2018

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 11, 2014

    SYNCHRON® LX20 ANALYZER (WITHOUT CAP PIERCER)

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·November 3, 2010

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITI·December 29, 2012

    BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JCF·June 5, 2018

    Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 4, 2013

    AXIOM Sireskop SD Model numbers 8890415 and 8890407. The product is intended for use as radiographic and fluoroscopic imaging device.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code MQB·January 8, 2009

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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