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
K193017EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WPNovember 22, 2019
K193031EXPD 4343P, EXPD 3643PNovember 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