Sedecal., Sa. FDA Approvals

0 new drug approvals and 5 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
SM-IV510(k)Aug 21, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Aug 21, 2023
SM-V510(k)Nov 21, 2022Radiology	Radiology	510(k)Substantially Equivalent (Abbreviated)	Nov 21, 2022
PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.510(k)Jul 18, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jul 18, 2022
PHOENIX510(k)Sep 14, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 14, 2021
Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems510(k)Feb 1, 2021Radiology	Radiology	510(k)Substantially Equivalent (Abbreviated)	Feb 1, 2021