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Well Lead Medical Co., Ltd.

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

Total Devices12
Categories9
Latest Approval2025-03-05
TypeNumberDevice NameCodeDate
510(k) K241734 Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact GBM 2025-03-05 View
510(k) K220722 PVC Hydrophilic Urethral Catheter EZD 2023-05-22 View
510(k) K220036 Wellead Ureteral Catheter KOD 2022-12-16 View
510(k) K211543 Wei Nasal Jet Tube BTR 2022-07-21 View
510(k) K211814 Wellead Endoscopic Seal ODC 2022-01-14 View
510(k) K202134 Well Lead All Silicone Foley Catheter with Temperature Sensor EZL 2021-04-08 View
510(k) K203119 ClearPetra Suction-Evacuation Sheath FED 2020-12-09 View
510(k) K182739 Endotracheal Tube with Evacuation Lumen BTR 2019-12-11 View
510(k) K162340 Stomach Tube KNT 2017-10-11 View
510(k) K160801 Well Lead Extraction Bag GCJ 2016-11-29 View
510(k) K161110 ClearPetra Suction-Evacuation Sheath FED 2016-10-12 View
510(k) K151084 Well Lead Ureteral Access Sheath FED 2016-01-07 View