Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

DRTECH Corporation

FDA 510(k) & PMA Approved Devices — 22 products

Total Devices22
Categories6
Latest FDA decision2025-06-10
TypeNumberDevice NameCodeDateActions
510(k) K250010 EXTRON 3; EXTRON 5; EXTRON 7OWB2025-06-10 View
510(k) K242770 EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PGMQB2025-03-20 View
510(k) K243443 EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NPMQB2025-03-19 View
510(k) K242591 XERO-alphaEHD2024-11-01 View
510(k) K242847 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);KPR2024-10-23 View
510(k) K240243 EConsole2LLZ2024-09-23 View
510(k) K233530 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)KPR2024-07-26 View
510(k) K232082 EXPD 4343SMQB2024-02-13 View
510(k) K232753 EXPD 4343D; EXPD 3643DMQB2023-11-16 View
510(k) K231225 EConsole1LLZ2023-10-18 View
510(k) K230871 EXTRON 5; EXTRON 7OWB2023-08-17 View
510(k) K231959 EXPD 4357; EXPD 4357PMQB2023-08-01 View
510(k) K220073 RMF-2000MUE2023-01-26 View
510(k) K223124 EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PGMQB2022-11-18 View
510(k) K193017 EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WPMQB2019-11-22 View
510(k) K193031 EXPD 4343P, EXPD 3643PMQB2019-11-22 View
510(k) K192400 EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AGMQB2019-10-03 View
510(k) K171137 EVS 2430W, EVS 2430GWMQB2017-05-15 View
510(k) K170930 RSM 2430CMUE2017-04-27 View
510(k) K162670 RSM 1824C with RConsole1MUE2017-02-23 View

Page 1 of 2