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

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    BQ/BM INTEGRATED LASER DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Neodent Instrument Kit Cases

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MEH·October 15, 2025

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 15MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·June 5, 2024

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 5, 2013

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·February 8, 2011

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·August 8, 2014

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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