Smwmed, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Smwmed, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)
1
Total
1
Cleared
0
Denied
Smwmed, Inc. specializes in Cardiovascular medical devices, with a manufacturing facility in San Diego, US.
The company has received 1 FDA 510(k) clearances from 1 total submissions. Smwmed, Inc. focuses exclusively on Cardiovascular devices. The company achieved its first clearance in 2026 and remains active in regulatory submissions.
Explore the company's cleared device names, product codes, and clearance dates in the database.
510(k) submissions have been managed by Feiying Drug & Medical Consulting Technical Service Group as regulatory consultant.
FDA 510(k) Regulatory Record - Smwmed, Inc.
1 devices