BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    ROTOR SYSTEMS A/S-400 & LA/S-400

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Hana/ProFx Traction Boot Small (pr)

    FDA UDI
    MIZUHO ORTHOPEDIC SYSTEMS, INC.·00842430106668·Left and Right boots

    AVERT Contrast Modulation System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    20.8-INCH(53CM) MONOCHROME LCD MONITOR MDL2110A (ME351I), (DV3MM-HB)

    FDA 510(k)
    FDA Class 2 ·Radiology

    ZILVER PTX 35 DRUG-ELUTING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code NIU·May 20, 2014

    LIGACLIP** ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·October 1, 2010

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 27, 2012

    LOGIC CR FEMORAL POR, LEFT, SZ 5

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 29, 2023

    LOGIC CR TIB INSERT STD, SZ 5, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 23, 2024

    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