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

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    APTUS® 3.5 TriLock Straight Plates

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 26, 2017

    MODIFICATION TO MODULAR PLUS REVISION STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPTUM TELEHEALTH APPLICATION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    BATTERY 14.8V, 6.3 AH LI-ION BATTERY

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MJK·October 15, 2014

    ADVIA CENTAUR PROGESTERONE (PRGE)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JLS·September 1, 2011

    MATNEU SCR Ø1.5 SELF-DRILL L5 TAN 1U I/C

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code JEY·July 17, 2013

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025