Annalise-Ai Pty , Ltd. FDA Approvals

0 new drug approvals and 6 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
Annalise Enterprise CTB Triage Trauma510(k)Sep 22, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 22, 2023
Annalise Enterprise CTB Triage Trauma510(k)Sep 22, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 22, 2023
Annalise Enterprise CTB Triage-OH510(k)Aug 15, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 15, 2023
Annalise Enterprise CTB Triage Trauma510(k)Apr 3, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 3, 2023
Annalise Enterprise CXR Triage Trauma510(k)Mar 28, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 28, 2023
Annalise Enterprise CXR Triage Trauma510(k)Mar 28, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 28, 2023