Medical Device Manufacturer · US , Lakewood , OH

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

7 submissions · 7 cleared · Since 1997

Recent clearances: TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050, TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840, TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040

View 7 510(k) Devices ↓

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Tiara Medical Systems, Inc. Anesthesiology ✕

7 devices

1-7 of 7

Cleared Nov 04, 2005

TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020,...

Anesthesiology · 142d

Cleared Jan 19, 2005

TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840

Anesthesiology · 41d

Cleared Jun 24, 2004

TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020,...

Anesthesiology · 177d

Cleared Mar 03, 2004

TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530

Anesthesiology · 254d

Cleared Jul 23, 2001

ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520,...

Anesthesiology · 7d

Cleared May 12, 2000

AIRPILOTMASK, MODEL TMS-900

Anesthesiology · 318d

Cleared Jul 31, 1997

TMS COMFORT SERIES NASAL CPAP MASK

Anesthesiology · 293d