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Koelis

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K180970 Disposable guides KDNG00ITX2018-07-10 View
510(k) K171040 Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO rangeITX2017-07-31 View
510(k) K170521 TRINITY/3D PROSTATE SUITEIYN2017-05-30 View
510(k) K160357 TRINITYIYN2016-05-02 View
510(k) K131448 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTIONLLZ2013-07-26 View
510(k) K100793 UROSTATION 3D PROSTATE SUITELLZ2010-09-22 View
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