Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)— 510(k) K253070

Clearance details

Applicant

Medline Industries, LP

Product code

Code DXC

Device class

Class 2

Regulation

21 CFR 870.4450

Advisory panel

Cardiovascular

Date received

2025-09-23

Decision date

2025-11-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Northfiled, IL, US

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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 →