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

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    BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    8.7 mm X 115 mm iFuse TORQ TNT Implant

    FDA UDI
    Si-Bone Inc.·00810055524310·8.7 mm X 115 mm iFuse TORQ TNT Implant

    SCANNERS, TOMOGRAPHIC, COMPUTED

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTERIAL DIAGNOSTIC UNIT (ADU)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THERAKOS XTS SYSTEM

    FDA Adverse Event
    Malfunction ·THERAKOS, INC.·Product code LNR·April 29, 2014

    PUMP MMT-523LNAS PRDGM INS V2.3 SK EN LN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·October 11, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·December 12, 2012

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

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

    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