U-100 INSULIN SYRINGE— 510(k) K822083

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K822083 for U-100 INSULIN SYRINGE, Substantially Equivalent on 1982-08-16. Applicant: Terumo Medical Corp..

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1982-07-12
Decision date: 1982-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.