BEUDAMED
    12 results · 38ms · Sources: EU EUDAMED, US FDA

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    Freedom Ultra-Congruent CR Tibial Liner

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oticon

    FDA UDI
    Oticon A/S·05707131331502·OPN 2, KIT IIC 10 75 C005

    PALLA M SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAXTORQUE MINI CANNULATED SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 26, 2024

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HSD·February 12, 2024

    ENDOPOUCH RETRIEVER SPEC BAG

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GCJ·October 3, 2008

    SYNCHRON® IRON / TIBC CALIBRATOR

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CKA·July 28, 2011

    TRIAGE CARDIAC PANEL KIT (25T)

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code MMI·June 14, 2013

    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

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024