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

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    VENT CORP PIB IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    CATHETER HOLDER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HUMAN SERUM ANTICONVULSANT DRUG CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    G7 SCREW HOLE PLUG

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·May 26, 2017

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 21, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code LWS·October 19, 2010

    CAPSURE EPI

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DTB·December 14, 2012

    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; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025