DRTECH Corporation

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
25
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250010EXTRON 3; EXTRON 5; EXTRON 7June 10, 2025
K242770EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PGMarch 20, 2025
K243443EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1March 19, 2025
K242591XERO-alphaNovember 1, 2024
K242847EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FOctober 23, 2024
K240243EConsole2September 23, 2024
K233530EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FJuly 26, 2024
K232082EXPD 4343SFebruary 13, 2024
K232753EXPD 4343D; EXPD 3643DNovember 16, 2023
K231225EConsole1October 18, 2023
K230871EXTRON 5; EXTRON 7August 17, 2023
K231959EXPD 4357; EXPD 4357PAugust 1, 2023
K220073RMF-2000January 26, 2023
K223124EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PGNovember 18, 2022
K193031EXPD 4343P, EXPD 3643PNovember 22, 2019
K193017EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WPNovember 22, 2019
K192400EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AGOctober 3, 2019
K171137EVS 2430W, EVS 2430GWMay 15, 2017
K170930RSM 2430CApril 27, 2017
K162670RSM 1824C with RConsole1February 23, 2017