BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    SONOPAK/QS, SONOPAK

    FDA 510(k)
    FDA Class 1 ·Dental

    Gentle Threads™

    FDA UDI
    Biomet Orthopedics, LLC·00887868568060·

    REVISION GENTLE THREADS

    FDA UDI
    Biomet Orthopedics, LLC·00880304407091·

    ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNIVERSAL DELIVERY SYSTEM CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 9, 2013

    SIMPLEX P - CE TOBRA FD 10-PK

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS LIMERICK·Product code LOD·November 12, 2010

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014

    Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664

    FDA Enforcement
    Class II ·Completed·Cardinal Health 200, LLC·July 31, 2019

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017