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

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    INCSTAR ACTH IRMA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VARIAX

    FDA UDI
    Stryker GmbH·07613327123463·Insert, Distal Radius Dorsal Plates

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756554800·OPEN HEART TRAY

    Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TABLET VIEWER SOFTWARE FOR IMAGE SUITE

    FDA 510(k)
    FDA Class 2 ·Radiology

    COATED VICRYL (POLYGLACTIN 910)SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 25, 2006

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 25, 2006

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 25, 2006

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 25, 2006

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·May 3, 2006

    COATED VICRYL ( POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·May 5, 2006

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·May 5, 2006

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Other ·ETHICON, INC.·Product code GAM·May 26, 2006

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·April 25, 2006

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON LABORATORIES IRELAND LTD.·Product code HQL·June 19, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·February 2, 2013

    PIONEER MATTRESS 30"

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code IKY·December 9, 2010

    Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.

    FDA Enforcement
    Class II ·Terminated·Capintec Inc·April 1, 2020

    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

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026