TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES— 510(k) K053413

Substantially Equivalent

Terumo Europe N.V.

FDA 510(k) clearance K053413 for TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, Substantially Equivalent on 2006-04-06. Applicant: Terumo Europe N.V..

Clearance details

Applicant: Terumo Europe N.V.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2005-12-07
Decision date: 2006-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

Download summary PDF View on FDA.gov ↗

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.