Well Lead Medical Co., Ltd. - FDA 510(k) Cleared Devices
17
Total
17
Cleared
0
Denied
Well Lead Medical Co., Ltd. has 17 FDA 510(k) cleared gastroenterology & urology devices. Based in Apollo Beach, US.
Latest FDA clearance: Mar 2025. Active since 2009.
Browse the complete list of FDA 510(k) cleared gastroenterology & urology devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Mid-Link Consulting Co, Ltd. as regulatory consultant.
17 devices
Cleared
Mar 05, 2025
Wellead® Hydrophilic Intermittent Catheter Ready to Use
Gastroenterology & Urology
261d
Cleared
May 22, 2023
PVC Hydrophilic Urethral Catheter
Gastroenterology & Urology
434d
Cleared
Dec 16, 2022
Wellead Ureteral Catheter
Gastroenterology & Urology
345d
Cleared
Jul 21, 2022
Wei Nasal Jet Tube
Anesthesiology
428d
Cleared
Jan 14, 2022
Wellead Endoscopic Seal
Gastroenterology & Urology
217d
Cleared
Apr 08, 2021
Well Lead All Silicone Foley Catheter with Temperature Sensor
Gastroenterology & Urology
251d
Cleared
Dec 09, 2020
ClearPetra Suction-Evacuation Sheath
Gastroenterology & Urology
54d
Cleared
Dec 11, 2019
Endotracheal Tube with Evacuation Lumen
Anesthesiology
439d
Cleared
Oct 11, 2017
Stomach Tube
Gastroenterology & Urology
415d
Cleared
Nov 29, 2016
Well Lead Extraction Bag
General & Plastic Surgery
251d
Cleared
Oct 12, 2016
ClearPetra Suction-Evacuation Sheath
Gastroenterology & Urology
175d
Cleared
Jan 07, 2016
Well Lead Ureteral Access Sheath
Gastroenterology & Urology
260d
Cleared
Dec 15, 2014
WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER
Gastroenterology & Urology
272d
Cleared
Oct 28, 2014
Well Lead PVC Urethral Catheter
Gastroenterology & Urology
47d
Cleared
Feb 24, 2014
WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER
Gastroenterology & Urology
91d
Cleared
Aug 26, 2011
WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL
Anesthesiology
211d
Cleared
Oct 16, 2009
WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR
Gastroenterology & Urology
147d