BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    COSMET

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SeaSpine Spacer System - Pacifica

    FDA UDI
    Seaspine Orthopedics Corporation·10889981088729·Paddle Distractor, Long, 12mm

    CONSURE STOOL MANAGEMENT SYSTEM

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

    RadiForce MX317W

    FDA 510(k)
    FDA Class 2 ·Radiology

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - CORK·Product code MCX·December 20, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 14, 2014

    ZOOM CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·December 21, 2012

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

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

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; 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