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

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    HEMO-CATH SILICONE ACCESS CATHETER

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

    SCREW-IN GUIDE TO GUIDE THREADS

    FDA Adverse Event
    Injury ·STRYKER·Product code HWC·December 28, 2017

    CORDIS REFLEX STEERABLE GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BRONCHOSCOPE BF-N20

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DTQ·January 9, 2013

    BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.2X4M

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code JEY·November 5, 2010

    FLEX-SEAL FMS FECAL MGMT SYS KIT

    FDA Adverse Event
    Malfunction ·CONVATEC INC·Product code KNT·February 25, 2014

    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·May 16, 2018