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

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    System 83 Plus Washer/Disinfector

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

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668109052·DALK AIR INJECTION CANNULA 27GA

    KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    VINYL EXAMINATION POWDER FREE GLOVES, CLEAR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SENSOR ENLITE

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·October 15, 2014

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 17, 2013

    VANGUARD CR FEMORAL 67.5MM RIGHT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MBH·July 23, 2011

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020