3DOSE 1ml Syringe— 510(k) K250733

Substantially Equivalent

Bimed Teknik Aletler Sanayi & Ticaret A.S.

FDA 510(k) clearance K250733 for 3DOSE 1ml Syringe, Substantially Equivalent on 2025-07-03. Applicant: Bimed Teknik Aletler Sanayi & Ticaret A.S..

Clearance details

Applicant: Bimed Teknik Aletler Sanayi & Ticaret A.S.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2025-03-11
Decision date: 2025-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Istanbul, TR

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.