E.N.S.I. RETRACTABLE SAFETY SYRINGE— 510(k) K003348

Substantially Equivalent

Ensi-Med International Pty. , Ltd.

FDA 510(k) clearance K003348 for E.N.S.I. RETRACTABLE SAFETY SYRINGE, Substantially Equivalent on 2001-01-12. Applicant: Ensi-Med International Pty. , Ltd..

Clearance details

Applicant: Ensi-Med International Pty. , Ltd.
Product code: Code MEG
Advisory panel: General Hospital
Date received: 2000-10-26
Decision date: 2001-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seaford, Victoria, AU

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Adverse events under product code MEG

product code MEG

Malfunction: 1,373
Other: 1
Total: 1,374

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.