K253070

Substantially Equivalent

Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)

Applicant: Medline Industries, LP
Product code: DXC
Advisory panel: Cardiovascular
Date received: 2025-09-23
Decision date: 2025-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northfiled, IL, US

Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.