BONE & MARROW CLLECTION SYSTEM— 510(k) K971268

Substantially Equivalent

Biomedical International Corp.

FDA 510(k) clearance K971268 for BONE & MARROW CLLECTION SYSTEM, Substantially Equivalent on 1997-07-03. Applicant: Biomedical International Corp..

Clearance details

Applicant: Biomedical International Corp.
Product code: Code GEY
Advisory panel: General, Plastic Surgery
Date received: 1997-04-07
Decision date: 1997-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

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Adverse events under product code GEY

product code GEY

Malfunction: 7,488
Total: 7,488

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.