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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    TriSalus TriGuideTM Guiding Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TENSYN BAND

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LIFEPAK CR PLUS DEFIBRILLATOR

    FDA Adverse Event
    Injury ·PHYSIO-CONTROL, INC.·Product code MKJ·November 13, 2008

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·September 4, 2011

    MICRO SAGITTAL SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·July 18, 2013

    Oxoid Agglutinating Sera, Salmonella 9-0 R30957301

    FDA Enforcement
    Class II ·Ongoing·Remel Europe Ltd.·April 29, 2026

    K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·July 10, 2019

    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