TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE— 510(k) K113422

Substantially Equivalent

Terumo (Philippines) Corporation

FDA 510(k) clearance K113422 for TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE, Substantially Equivalent on 2012-03-05. Applicant: Terumo (Philippines) Corporation.

Clearance details

Applicant: Terumo (Philippines) Corporation
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2011-11-21
Decision date: 2012-03-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Binan, Laguna, PH

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Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.