BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    twiist Automated Insulin Delivery (AID) System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COE®

    FDA UDI
    Gc America Inc.·D6582616721·COE® STO-K Impression Trays Solid U-12-O

    COE®

    FDA UDI
    Gc America Inc.·10386040012300·COE® STO-K Impression Trays Solid U-12-O

    SpeediCath Flex Coude

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

    SYNAPSE MIP/MPR IMAGE VISUALIZATION SOFTWARE OBLIQUUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 19, 2014

    IMPLANTABLE SPINAL FUSION STIMULATOR

    FDA Adverse Event
    Injury ·EBI, LLC·Product code LOE·September 23, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·August 2, 2013

    Quad Kit W/03ML Flush Device, Mounts, Reservoir & TP4, Item No. 46099-24 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016