DeviceClearance

K020999

Substantially Equivalent

MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL

Applicant
Medefil, Inc.
Product code
NGT
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Schaumburg, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code NGT

product code NGT
Death
12
Malfunction
2,008
Other
4
Total
2,024

Source: openFDA MAUDE database, through . 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.