BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    Knotless SutureTak Anchors

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MS SYSTEM (NARROW RIDGE)

    FDA 510(k)
    FDA Class 2 ·Dental

    ELECSYS TROPONIN I CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BIODESIGN OTOLOGIC REPAIR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code KHJ·January 11, 2018

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    2.0MM TI LCKNG SCREW SLF-TPNG W/PLUSDRIVE(TM) RECESS 6MM

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·October 17, 2014

    Allura Xper FD10; Model Number: 722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

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

    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