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Well Lead Medical Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
17
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter March 5, 2025
K220722PVC Hydrophilic Urethral CatheterMay 22, 2023
K220036Wellead Ureteral CatheterDecember 16, 2022
K211543Wei Nasal Jet TubeJuly 21, 2022
K211814Wellead Endoscopic SealJanuary 14, 2022
K202134Well Lead All Silicone Foley Catheter with Temperature SensorApril 8, 2021
K203119ClearPetra Suction-Evacuation SheathDecember 9, 2020
K182739Endotracheal Tube with Evacuation LumenDecember 11, 2019
K162340Stomach TubeOctober 11, 2017
K160801Well Lead Extraction BagNovember 29, 2016
K161110ClearPetra Suction-Evacuation SheathOctober 12, 2016
K151084Well Lead Ureteral Access SheathJanuary 7, 2016
K140667WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETERDecember 15, 2014
K142563Well Lead PVC Urethral CatheterOctober 28, 2014
K133615WELL LEAD PVC HYDROPHILIC URETHRAL CATHETERFebruary 24, 2014
K110269WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORALAugust 26, 2011
K091516WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOROctober 16, 2009