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

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    GIOTTO MAMMOGRAPHY HF

    FDA 510(k)
    FDA Class 2 ·Radiology

    Printed Lower ROC Pack for Herbst LR7 10mm

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199015580·

    BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CARDIOSAVE HYBRID, TYPE B PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·June 2, 2025

    THERMOPHORE HEATING PAD

    FDA Adverse Event
    BATTLE CREEK EQUIPMENT·Product code IRT·June 18, 2014

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code MTA·January 4, 2013

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·November 12, 2010

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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