Company ยท KR
DRTECH Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.
33510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 8, 2026 | K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H DRTECH Corporation, KR | KPR |
| Aug 19, 2026 | K261413 | EXTRON 3;EXTRON 6 DRTECH Corporation, KR | OWB |
| Jun 10, 2025 | K250010 | EXTRON 3; EXTRON 5; EXTRON 7 DRTECH Corporation, KR | OWB |
| Mar 20, 2025 | K242770 | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG DRTECH Corporation, KR | MQB |
| Mar 19, 2025 | K243443 | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD DRTECH Corporation, KR | MQB |
| Nov 1, 2024 | K242591 | XERO-alpha DRTECH Corporation, KR | EHD |
| Oct 23, 2024 | K242847 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXS DRTECH Corporation, KR | KPR |
| Sep 23, 2024 | K240243 | EConsole2 DRTECH Corporation, KR | LLZ |
| Jul 26, 2024 | K233530 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXS DRTECH Corporation, KR | KPR |
| Feb 13, 2024 | K232082 | EXPD 4343S DRTECH Corporation, KR | MQB |
| Nov 16, 2023 | K232753 | EXPD 4343D; EXPD 3643D DRTECH Corporation, KR | MQB |
| Oct 18, 2023 | K231225 | EConsole1 DRTECH Corporation, KR | LLZ |
| Aug 17, 2023 | K230871 | EXTRON 5; EXTRON 7 DRTECH Corporation, KR | OWB |
| Aug 1, 2023 | K231959 | EXPD 4357; EXPD 4357P DRTECH Corporation, KR | MQB |
| Jan 26, 2023 | K220073 | RMF-2000 DRTECH Corporation, KR | MUE |
| Nov 18, 2022 | K223124 | EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG DRTECH Corporation, KR | MQB |
| Nov 22, 2019 | K193031 | EXPD 4343P, EXPD 3643P DRTECH Corporation, KR | MQB |
| Nov 22, 2019 | K193017 | EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP DRTECH Corporation, KR | MQB |
| Oct 3, 2019 | K192400 | EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG DRTECH Corporation, KR | MQB |
| May 15, 2017 | K171137 | EVS 2430W, EVS 2430GW DRTECH Corporation, KR | MQB |
| Apr 27, 2017 | K170930 | RSM 2430C DRTECH Corporation, KR | MUE |
| Feb 23, 2017 | K162670 | RSM 1824C with RConsole1 DRTECH Corporation, KR | MUE |
| Dec 21, 2016 | K162555 | EVS 4343, EVS 4343G DRTECH Corporation, KR | MQB |
| Dec 2, 2016 | K162552 | EVS 3643, EVS 3643G DRTECH Corporation, KR | MQB |
| Dec 14, 2015 | K152172 | Econsole1 DRTECH Corporation, KR | LLZ |
| Oct 21, 2015 | K151942 | EVS 3643 DRTECH Corporation, KR | MQB |
| Jan 15, 2015 | K142475 | EVS 4343 DRTECH Corporation, KR | MQB |
| Feb 21, 2014 | K132842 | FLAATZ 600 SERIES (FLAATZ 600/601) Drtech Corp., KR | MQB |
| Nov 30, 2011 | K111655 | FLAATZ 760 Drtech Corp., KR | KPR |
| Oct 4, 2011 | K111583 | FLAATZ 560 Drtech Corp., KR | MQB |
| Mar 4, 2011 | K102474 | FLAATZ 750E Drtech Corp., KR | MQB |
| Jul 1, 2009 | K091747 | FLAATZ 500 Drtech Corp., KR | KPR |
| Jan 23, 2008 | K080064 | FLAATZ 750 Drtech Corp., KR | MQB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||