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Well Lead Medical Co., Ltd.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories9
Latest FDA decision2025-03-05
TypeNumberDevice NameCodeDateActions
510(k) K241734 Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactGBM2025-03-05 View
510(k) K220722 PVC Hydrophilic Urethral CatheterEZD2023-05-22 View
510(k) K220036 Wellead Ureteral CatheterKOD2022-12-16 View
510(k) K211543 Wei Nasal Jet TubeBTR2022-07-21 View
510(k) K211814 Wellead Endoscopic SealODC2022-01-14 View
510(k) K202134 Well Lead All Silicone Foley Catheter with Temperature SensorEZL2021-04-08 View
510(k) K203119 ClearPetra Suction-Evacuation SheathFED2020-12-09 View
510(k) K182739 Endotracheal Tube with Evacuation LumenBTR2019-12-11 View
510(k) K162340 Stomach TubeKNT2017-10-11 View
510(k) K160801 Well Lead Extraction BagGCJ2016-11-29 View
510(k) K161110 ClearPetra Suction-Evacuation SheathFED2016-10-12 View
510(k) K151084 Well Lead Ureteral Access SheathFED2016-01-07 View
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