Quantel Medical 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
INTEGRE LIO510(k)Feb 6, 2026Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Feb 6, 2026
Pocket III510(k)Apr 26, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 26, 2024
Capsulo510(k)May 12, 2022Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	May 12, 2022
Axialis Ophthalmic Ultrasound System510(k)Nov 15, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 15, 2021