MONOJECT INSULIN SYRINGE— 510(k) K991758

Substantially Equivalent

The Kendal Co.

FDA 510(k) clearance K991758 for MONOJECT INSULIN SYRINGE, Substantially Equivalent on 1999-06-14. Applicant: The Kendal Co..

Clearance details

Applicant: The Kendal Co.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1999-05-24
Decision date: 1999-06-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Mansfield, MA, 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.