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

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    Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Key Surgical K-Wires and Steinmann Pins

    FDA UDI
    KEY SURGICAL, INC.·00849771012542·K-Wires, Single trocar, .035-inch (.9mm) diamet...

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704292800·

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771049125·K-Wires, Single trocar, .035-inch (.9mm) diamet...

    PERFSCAPE V2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    ENDOSSEOUS DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ISA CO2

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 30, 2022

    ECHELON LINEAR CUTTER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 14, 2014

    CELSIUS¿ ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·June 14, 2013

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·July 1, 2011

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018