BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    coDiagnostiX

    FDA 510(k)
    FDA Class 2 ·Dental

    HHM

    FDA UDI
    Oticon A/S·05707131341808·G100, BTE 13 PP 2.4G 105 C091 HHM

    CONCENPIECE,HIGH-SPEED HANDPIECE SERIES

    FDA 510(k)
    FDA Class 1 ·Dental

    TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OMNIFIX®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FMF·March 6, 2026

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 13, 2011

    PERMANENT CAUTERY HOOK INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 27, 2013

    FREESTYLE LIBRE 14 DAY

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC·Product code PZE·September 5, 2023

    FREE STYLE LIBRE 2

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code QLG·June 10, 2022

    ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;

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

    Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; 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

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

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