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Siemens Healthineers AG FDA Approvals

0 new drug approvals and 5 device clearances on file. Matched by name to SMMNY.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure510(k)Jul 31, 2026Radiology
LungMaps510(k)Jun 15, 2026Radiology
BIOGRAPH One510(k)Jan 15, 2026Radiology
syngo.MR Applications (VB80)510(k)Nov 20, 2025Radiology
Syngo Carbon Clinicals (VA41)510(k)Oct 24, 2025Radiology

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