DeviceClearance

K214007

Substantially Equivalent

HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap

Applicant
Owens & Minor (O&M) Halyard, Inc.
Product code
FRG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mechanicsville, VA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FRG

product code FRG
Other
3
Total
3

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.