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DRTECH Corporation FDA Approvals

0 new drug approvals and 16 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
EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H510(k)Sep 8, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 8, 2026
EXTRON 3;EXTRON 6510(k)Aug 19, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 19, 2026
EXTRON 3; EXTRON 5; EXTRON 7510(k)Jun 10, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 10, 2025
EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG510(k)Mar 20, 2025Radiology	Radiology	510(k)Substantially Equivalent (Special)	Mar 20, 2025
EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP510(k)Mar 19, 2025Radiology	Radiology	510(k)Substantially Equivalent (Special)	Mar 19, 2025
XERO-alpha510(k)Nov 1, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Nov 1, 2024
EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA);510(k)Oct 23, 2024Radiology	Radiology	510(k)Substantially Equivalent (Special)	Oct 23, 2024
EConsole2510(k)Sep 23, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 23, 2024
EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM)510(k)Jul 26, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 26, 2024
EXPD 4343S510(k)Feb 13, 2024Radiology	Radiology	510(k)Substantially Equivalent (Special)	Feb 13, 2024
EXPD 4343D; EXPD 3643D510(k)Nov 16, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Nov 16, 2023
EConsole1510(k)Oct 18, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 18, 2023
EXTRON 5; EXTRON 7510(k)Aug 17, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 17, 2023
EXPD 4357; EXPD 4357P510(k)Aug 1, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Aug 1, 2023
RMF-2000510(k)Jan 26, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 26, 2023
EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG510(k)Nov 18, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	Nov 18, 2022

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