Company ยท US
Eigen
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2023. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 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 |
|---|---|---|---|
| Oct 12, 2023 | K222222 | Artemis, Artemis TPO, Artemis MX Eigen | QTZ |
| Nov 21, 2018 | K173744 | ProFuse CAD Eigen | LLZ |
| Oct 21, 2016 | K162474 | Artemis Eigen | LLZ |
| Aug 29, 2008 | K082341 | DSA 2000EX Eigen, LLC | LLZ |
| May 1, 2008 | K081093 | 3-D IMAGING WORKSTATION Eigen, LLC | LLZ |
| Jan 26, 2007 | K063846 | EIGEN DSA 2000 Eigen | LLZ |
| Apr 7, 1994 | K933115 | DIGITAL DISK RECORDER Eigen | LMB |
| Nov 23, 1992 | K924164 | DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT Eigen | JAA |
| Oct 21, 1992 | K923585 | DIGITAL FLUORO STORE Eigen | JAA |
| Sep 23, 1991 | K913012 | DIGITAL FLUORO STORE(DFS) W/NUMERICAL SUFFIXES Eigen | JAA |
| Jan 25, 1991 | K905111 | DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES Eigen | JAA |
| Nov 7, 1990 | K903821 | PSC-1 W/OTHER NUMERICAL Eigen | JAA |
| Aug 3, 1990 | K902927 | DIGITAL PHOTOSPOT Eigen | JAA |
| Jul 2, 1990 | K901956 | DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.) Eigen | LMB |
| Mar 14, 1989 | K890745 | SC-1000 WITH SUFFIXES (SCAN CONVERTER) Eigen | JAA |
| Aug 19, 1988 | K882175 | HR-2000 W/SUFFIXES B,C,D, CARDIO & DIGI LOOP, DDVP Eigen | JAA |
| Aug 11, 1988 | K882176 | VTR-12 Eigen | JAA |
| Jun 28, 1988 | K882184 | HR-1000 W/SUFFIXES (B,C OR D) Eigen | LMB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||