BEUDAMED
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    AngioDynamics Total Abscession Biliary Drainage Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Z6 STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ATLAS SPINE PIVOTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 2, 2025

    GYNECARE GYNEMESH* PS

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTO·June 14, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·June 21, 2011

    TERUMO CENTRIFUGAL SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·September 15, 2008

    BD PLASTIPAK¿ SYRINGES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·September 5, 2023

    ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES PR·Product code JXG·October 30, 2017

    ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES PR·Product code JXG·October 30, 2017

    ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES PR·Product code JXG·October 30, 2017

    ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES PR·Product code JXG·October 30, 2017

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

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