DeviceClearance

K962755

Substantially Equivalent

STRYKER ENCORE STERILIZER

Applicant
Stryker Corp.
Product code
FLE
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Kalamazoo, MI, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FLE

product code FLE
Malfunction
444
Total
444

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.