BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE— 510(k) K984162

Name: FDA 510(k) clearance K984162
Creator: U.S. Food and Drug Administration
Published: 1999-06-28

Substantially Equivalent

Nobelpharma USA, Inc.

FDA 510(k) clearance K984162 for BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE, Substantially Equivalent on 1999-06-28. Applicant: Nobelpharma USA, Inc.. Device class: 2.

Clearance details

Applicant: Nobelpharma USA, Inc.
Product code: Code MAH
Device class: Class 2
Regulation: 21 CFR 874.3302
Advisory panel: Ear, Nose, Throat
Date received: 1998-11-19
Decision date: 1999-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westmont, IL, US

Download summary PDF View on FDA.gov ↗

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K962130 — BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE1996-07-22
K961736 — 17 ANGULATED ABUTMENT1996-07-18
K961728 — MIRUSCONE ABUTMENT SYSTEM1996-07-10

Adverse events under product code MAH

product code MAH

Injury: 4,155
Total: 4,155

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.