Medical Device Manufacturer · US , Anaheim , CA

Allwin Medical Devices, Inc. - FDA 510(k) Cleared Devices

7 submissions · 6 cleared · Since 2019

Recent clearances: ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter, allFlex Ureteral Catheters, Krait Ureteral Catheters, SureStrip Vitrification Straw, SureLock Vitrification Straw

7

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Allwin Medical Devices, Inc. Gastroenterology & Urology ✕

3 devices

1-3 of 3

Cleared May 05, 2023

ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA...

Gastroenterology & Urology · 414d

Cleared Oct 13, 2022

allFlex Ureteral Catheters, Krait Ureteral Catheters

Gastroenterology & Urology · 213d

Cleared Dec 02, 2019

Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via...

Gastroenterology & Urology · 263d