BEUDAMED
    12 results · 24ms · Sources: EU EUDAMED, US FDA

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    Y-KNOT ALL-SUTURE ANCHOR MODEL HF13

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WITH ONE NO. 2 WHITE/BLUE HI-FI SUTURE

    FDA Adverse Event
    Malfunction ·CONMED CORPORATION·Product code MBI·April 23, 2019

    CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·February 2, 2016

    VERCISE GENUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·August 9, 2024

    GORE TAG THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·April 30, 2013

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code MTA·September 23, 2014

    LUMAX 540 HF-T

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code MRM·May 25, 2011

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 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