Medical Device Manufacturer · US , Morganton , NC

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

6 submissions · 6 cleared · Since 1992

Recent clearances: SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100, SAFEPASS STERILIZATION POUCH, HTP-1500 LOCALIZED HEAT THERAPY PUMP

View 6 510(k) Devices ↓

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Adroit Medical Systems, Inc. Cardiovascular ✕

2 devices

1-2 of 2

Cleared Jun 06, 2008

SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100

Cardiovascular · 158d

Cleared Dec 11, 1992

Cardiovascular · 232d