Hermes Medical Solutions AB FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

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

Product	What it is	Route	Decided
Affinity510(k)Jul 31, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 31, 2026
Hybrid Viewer (00859873006240)510(k)Sep 9, 2025Radiology	Radiology	510(k)Substantially Equivalent (Special)	Sep 9, 2025
Voxel Dosimetry (00859873006226)510(k)Jul 30, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 30, 2025
Hybrid Viewer (00859873006189)510(k)Nov 8, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 8, 2024