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. Obstetrics & Gynecology ✕

4 devices

1-4 of 4

Cleared Jun 04, 2021

SureStrip Vitrification Straw, SureLock Vitrification Straw

Obstetrics & Gynecology · 175d

Cleared Jul 01, 2020

Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators

Obstetrics & Gynecology · 152d

Cleared Nov 25, 2019

Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK...

Obstetrics & Gynecology · 263d

Cleared Nov 14, 2019

Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip...

Obstetrics & Gynecology · 255d