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

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    CELSITE VENOUS SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·14026704920959·

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704284645·SCALP CONTOUR RETRACTOR 5 1/2" 3X4 SHARP

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471150669·K-WIRE - SINGLE TROCAR THREADED 2.4mm DIA x 200mm

    AXI+LINE Proximal Bunion Correction System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UROK ROCKING WHEELCHAIR, MODEL 700-4XX

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ATTAIN OTW

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWP·February 9, 2013

    SELUTE PICOTIP

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·January 7, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 23, 2014

    Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020