DeviceClearance

K192155

Substantially Equivalent

Smith & Nephew DYONICS 25 Fluid Management System

Applicant
Smith & Nephew, Inc.
Product code
HRX
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Andover, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX
Injury
623
Malfunction
11,257
Total
11,880

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.