Allengers Medical Systems Limited 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
Digital C-ARM with 3D510(k)Jun 5, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 5, 2026
Wireless/ Wired X-Ray Flat Panel Detectors510(k)Apr 18, 2025Radiology	Radiology	510(k)Substantially Equivalent (Special)	Apr 18, 2025
Wireless/Wired X-Ray Flat Panel Detectors510(k)Nov 27, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 27, 2022
DigiX FDX510(k)Oct 26, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Oct 26, 2022
Cardiovascular Angiography System510(k)May 3, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 3, 2022