BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    PASS/FAIL CHALLENGE PACK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    808 P37,IG,BE,2L,STKR

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828100977·808 P37,IG,BE,2L,STKR

    Dental Electrical Motor iRoot Pro

    FDA 510(k)
    FDA Class 1 ·Dental

    PERVENOUS LEAD INTRODUCER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 14, 2021

    NEFF PERCUTANEOUS ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KGZ·March 5, 2019

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 6, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011

    CAPSUREFIX NOVUS

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

    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