DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE— 510(k) K103736

Substantially Equivalent

Dmc Medical, Ltd.

FDA 510(k) clearance K103736 for DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE, Substantially Equivalent on 2011-06-10. Applicant: Dmc Medical, Ltd..

Clearance details

Applicant: Dmc Medical, Ltd.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2010-12-22
Decision date: 2011-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bountiful, UT, US

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.