HALIFAX BIOMEDICAL TANATLUM BEAD SET— 510(k) K103417

Substantially Equivalent

Halifax Biomedical, Inc.

FDA 510(k) clearance K103417 for HALIFAX BIOMEDICAL TANATLUM BEAD SET, Substantially Equivalent on 2011-06-28. Applicant: Halifax Biomedical, Inc..

Clearance details

Applicant: Halifax Biomedical, Inc.
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2010-11-22
Decision date: 2011-06-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Lake Hopatcong, NJ, US

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Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.