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

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    IMPEDE-FX Embolization Plug

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813019184·GLOVES PF VINYL SM HANDS ON DARBY

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704513233·

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100981·DESMARRES LID RETRACTOR #3

    MONICA AN24

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 10, 2013

    CARDIOVASCULAR PROCEDURE KIT

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code OEZ·July 11, 2011

    KII OPTICAL ACCESS 11MM

    FDA Adverse Event
    Other ·APPLIED MEDICAL RESOURCES·Product code GCJ·September 30, 2008

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMI·July 30, 2021

    BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·October 25, 2023

    BD PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·February 23, 2021

    DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·May 24, 2023

    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