Medical Device Manufacturer · US , Findley , MN

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

5 submissions · 5 cleared · Since 1999

Recent clearances: BAHA DIVINO, BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Entific Medical Systems, Inc. Ear, Nose, Throat ✕

5 devices

1-5 of 5

Cleared Aug 26, 2004

Ear, Nose, Throat · 30d

Cleared Aug 30, 2002

BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)

Ear, Nose, Throat · 87d

Cleared Jul 23, 2001

BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.

Ear, Nose, Throat · 74d

Cleared Oct 17, 2000

HEADBAND FOR BAHA

Ear, Nose, Throat · 29d

Cleared Nov 24, 1999

BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II

Ear, Nose, Throat · 90d