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FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories4
Latest FDA decision2025-12-05
TypeNumberDevice NameCodeDateActions
510(k) K250795 PUREVUE™ FMSHRX2025-12-05 View
510(k) K201361 PNEUMOCLEARHIF2020-07-29 View
510(k) K173311 ARTHRO-Pump PA304HRX2018-05-09 View
510(k) K173489 GYN-Pump PH304HIG2018-03-28 View
510(k) K172040 Aquilex Fluid Control System AQL-100SHIG2018-02-05 View
510(k) K170784 PNEUMOCLEARHIF2017-05-15 View
510(k) K163320 LAP-Pump PP110HET2017-03-21 View
510(k) K153513 Insufflator 50L FM134HIF2016-03-04 View
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