GERTIE MARX NEEDLE— 510(k) K943649

Substantially Equivalent

Manan Medical Products, Inc.

FDA 510(k) clearance K943649 for GERTIE MARX NEEDLE, Substantially Equivalent on 1995-03-22. Applicant: Manan Medical Products, Inc..

Clearance details

Applicant: Manan Medical Products, Inc.
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 1994-07-28
Decision date: 1995-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

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Adverse events under product code BSP

product code BSP

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.