MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY— 510(k) K121262

Substantially Equivalent

Medefil, Inc.

FDA 510(k) clearance K121262 for MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY, Substantially Equivalent on 2012-09-20. Applicant: Medefil, Inc..

Clearance details

Applicant: Medefil, Inc.
Product code: Code NGT
Advisory panel: General Hospital
Date received: 2012-04-26
Decision date: 2012-09-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Glendale Heights, IL, US

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Adverse events under product code NGT

product code NGT

Death: 12
Malfunction: 2,008
Other: 4
Total: 2,024

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.