STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES— 510(k) K053120

Substantially Equivalent

Excelsior Medical Corp.

FDA 510(k) clearance K053120 for STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES, Substantially Equivalent on 2005-12-09. Applicant: Excelsior Medical Corp..

Clearance details

Applicant: Excelsior Medical Corp.
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 2005-11-07
Decision date: 2005-12-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Neptune, NJ, US

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Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.