BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    3 PHASE HIGH FREQ. DIAG. X-RAY GEN. MICRO-X 60HF

    FDA 510(k)
    FDA Class 1 ·Radiology

    Sharpsite®

    FDA UDI
    MEDTRONIC XOMED, INC.·00613994455383·ENDOSCOPE 1880525 SHARPSITE FLEX 3.2MM

    NA

    FDA UDI
    STRYKER CORPORATION·07613327063691·25 Fr. Visual Urethrotome (Outer Sheath)

    COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W

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

    T-3 UPTAKE (SORBENT) KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·July 31, 2014

    3005075853-2010-05417

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·October 22, 2010

    ATLAS II VR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014

    MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·December 19, 2012

    Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021