Skip to content

Branenmark Bone-Anchored-Hearing Aid (Baha)

by Entific Medical Systems, Inc. 510(k)

Active United States

510(k) K021837

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK021837 Date30 Aug 2002ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LXB
Device Class
Class II
Regulation
21 CFR Part 874.3302
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Other devices from Entific Medical Systems, Inc.