ILIAC CREST BONE MARROW ASPIRATION NEEDLE— 510(k) K953082

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K953082 for ILIAC CREST BONE MARROW ASPIRATION NEEDLE, Substantially Equivalent on 1995-09-22. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code GDM
Advisory panel: General, Plastic Surgery
Date received: 1995-07-03
Decision date: 1995-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgaw Park, IL, US

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Adverse events under product code GDM

product code GDM

Death: 2
Total: 2

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.