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

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    Ezra Plexo Software

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMC PISTON SYRINGES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø42/+0MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·July 21, 2022

    STOCKERT 70 RF GENERATOR

    FDA Adverse Event
    Malfunction ·STOCKERT GMBH·Product code DRF·October 22, 2014

    ACL TIGHTROPE RT

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HTY·June 27, 2013

    THERMODILUTION VENOUS INFUSION PORT (VIP) FIVE LUMEN

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, LLC·Product code DYG·July 5, 2011

    PROAQT SENSOR

    FDA Adverse Event
    Malfunction ·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·December 1, 2023

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·September 30, 2025

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·June 20, 2024

    PROAQT SENSOR

    FDA Adverse Event
    Malfunction ·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code PKL·September 16, 2021

    Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·November 20, 2013