BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    NEXTRA TI HAMMERTOE CORRECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ArgenZ HT+ 98x16 C4

    FDA UDI
    ARGEN CORPORATION, THE·D818122031·Dental porcelain/ceramic restoration kit

    GALAXY LITE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 22, 2024

    HAHN TAPERED IMPLANT Ø3.5 X 16 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 10, 2025

    ORTHOPAT

    FDA Adverse Event
    Malfunction ·HAEMONETICS CORP.·Product code CAC·May 14, 2013

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·May 24, 2011

    LIGACLIP MCA MED APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDO·August 14, 2008

    COOK TURBO-FLO HD HEMODIALYSIS CATHETER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code MPB·February 13, 2017

    SEE H10 NARRATIVE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·May 16, 2023

    TIBIAL NAIL ADVANCED Ø11 L405

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·April 26, 2023

    TIBIAL NAIL-ADVANCED / 12MM 345MM / STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code JDS·August 15, 2023

    TIBIAL NAIL-ADVANCED / 9MM 375MM / STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code JDS·September 26, 2023

    CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code JEY·June 19, 2023

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 65MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code KTT·June 23, 2023

    CRANIAL-SCR PLUSDRIVE Ø1.6 SELF-DRILL L4

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code JEY·June 19, 2023

    SmartPath to dStream for 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781260

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020