K945715

Substantially Equivalent

MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZES

Applicant: Sherwood Medical Co.
Product code: FMF
Advisory panel: General Hospital
Date received: 1994-11-21
Decision date: 1995-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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.