Medical Device Manufacturer · US , Des Moines , IA

Qualis, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1997

Recent clearances: PERSONAL WARMING GEL, PERSONAL WARMING JELLY, PERSONAL LUBRICATING GEL

View 6 510(k) Devices ↓

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Qualis, Inc. Obstetrics & Gynecology ✕

5 devices

1-5 of 5

Cleared Mar 17, 2005

PERSONAL WARMING GEL

Obstetrics & Gynecology · 45d

Cleared Mar 17, 2005

PERSONAL WARMING JELLY

Obstetrics & Gynecology · 45d

Cleared Sep 24, 2004

PERSONAL LUBRICATING GEL

Obstetrics & Gynecology · 147d

Cleared Apr 20, 2004

PERSONAL WARMING LUBRICANT

Obstetrics & Gynecology · 95d

Cleared Nov 26, 1997

PERSONAL LUBRICATING LIQUID

Obstetrics & Gynecology · 54d