SEARE BIOMEDICAL NASAL IMPLANTS— 510(k) K982753

Name: FDA 510(k) clearance K982753
Creator: U.S. Food and Drug Administration
Published: 1998-09-30

Substantially Equivalent

Seare Biomedical Corp.

FDA 510(k) clearance K982753 for SEARE BIOMEDICAL NASAL IMPLANTS, Substantially Equivalent on 1998-09-30. Applicant: Seare Biomedical Corp.. Device class: 2.

Clearance details

Applicant: Seare Biomedical Corp.
Product code: Code FZE
Device class: Class 2
Regulation: 21 CFR 878.3680
Advisory panel: General, Plastic Surgery
Date received: 1998-08-06
Decision date: 1998-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FZE

view all

K241253 — Medicon Epiplating System2024-12-12
K161548 — Osseointegrated Fixtures2016-12-01
K090803 — HANSON MEDICAL FACIAL IMPLANTS2010-06-30
K090630 — NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)2009-06-02
K071018 — MONARCH NASAL IMPLANT2007-05-25

More clearances from Seare Biomedical Corp.

view all

K983630 — SEARE BIOMEDICAL SILICONE RODS1998-12-11
K983792 — SEARE BIOMEDICAL SILICONE TISSUE EXPANDER1998-12-11
K982752 — SEARE BIOMEDICAL CHIN IMPLANTS1998-09-30
K982762 — SEARE BIOMEDICAL PECTORALIS IMPLANT1998-09-30
K982763 — SEARE BIOMEDICAL MALAR IMPLANTS1998-09-30

Adverse events under product code FZE

product code FZE

Injury: 138
Total: 138

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.