BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017910·K-Wire, Double Ended, Trocar Point, Diameter Si...

    Oticon

    FDA UDI
    Oticon A/S·05707131339065·SIYA 1, MINIRITE T 312 2.4G C093

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017927·K-Wire, Double Ended, Trocar Point, Diameter 0....

    AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·October 21, 2014

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING·Product code FJI·June 21, 2013

    INTEGRATED POWER CONSOLE (IPC)

    FDA Adverse Event
    Malfunction ·MEDTRONIC POWERED SURGICAL SOLUTIONS·Product code HBE·July 29, 2011

    BACT/ALERT MP - 419744

    FDA Adverse Event
    Malfunction ·BIOMERIEUX INC.·Product code MDB·December 5, 2019

    BD SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 21, 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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024