BEUDAMED
    16 results · 43ms · Sources: EU EUDAMED, US FDA

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    ENTEROCOCCUS QUICKFISH BC

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ArgenZ HT+ 98x12 A1-L

    FDA UDI
    ARGEN CORPORATION, THE·D818121991·Dental porcelain/ceramic restoration kit

    BD BBL SENSI-DISC OXACILLIN - 1 G

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code JTN·July 2, 2021

    WEBSTER DUO-DECAPOLAR CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE

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

    BD LUER LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 4, 2018

    BD ULTRA FINE PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·January 31, 2020

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·May 21, 2013

    MX-PRO R-3 AMBULANCE COT

    FDA Adverse Event
    Other ·STRYKER MEDICAL·Product code INK·June 2, 2011

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 13, 2008

    HI-TORQUE PROGRESS 200T GUIDE WIRE

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR - CARDIAC THERAPIES·Product code DQX·October 26, 2010

    HI-TORQUE ADVANCE GUIDE WIRE

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR - CARDIAC THERAPIES·Product code DQX·October 26, 2010

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR CLONMEL·Product code MAF·September 16, 2010

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015