510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011438Substantially Equivalent

Bilateral Fitting of the Branemark Bone-Anchored Hearing Aid (Baha) System.

Entific Medical Systems, Inc., Findley MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011438 is the FDA 510(k) clearance record for BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM., a class II device, cleared for Entific Medical Systems, Inc. on under FDA product code LXB (Hearing Aid, Bone Conduction). FDA records list 5 510(k) clearances for Entific Medical Systems, Inc., from to . As of , FDA records show no recalls naming K011438.

Clearance record

Decision date
Received
(74 days to decision)
Product code
LXB Hearing Aid, Bone Conduction
Regulation
21 CFR 874.3302
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Entific Medical Systems, Inc. 6470 Riverview Ter., Findley MN
510(k) summary
Summary
Third party review
No

Clearances, product code LXB

Trailing 12 months
4 clearances under product code LXB in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LXB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20261
August 20261
September 20260
October 20260