Medical Device Manufacturer · US , Waukesha , WI

Hjarta Care, LLC - FDA 510(k) Cleared Devices

1 submissions · 0 cleared · Since 2026

1

Total

0

Cleared

1

Denied

FDA 510(k) Regulatory Record - Hjarta Care, LLC Cardiovascular ✕

1 devices

1-1 of 1

Not Cleared Apr 17, 2026

XplantR Explant Tool

DEN250033 · SHR

Cardiovascular · 253d