This page includes the latest FDA filings for Dixi Medical. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3014527920 |
| FEI Number | 3014527920 |
| Name | DIXI MEDICAL USA |
| Owner & Operator | DIXI Medical |
| Contact Address | 2A ROUTE DE POULIGNEY CHAUDEFONTAINE FR-25 Doubs 25640 FR |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 11910 Fox Ridge Drive Plymouth, MI 48170 US |
| Registration Number | 3007636029 |
| FEI Number | 3007636029 |
| Name | Mark LEMKO |
| Owner & Operator | DIXI Medical |
| Contact Address | 2A ROUTE DE POULIGNEY CHAUDEFONTAINE FR-25 Doubs 25640 FR |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 11910 FOX RIDGE DRIVE Plymouth, MI 48170 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| DIXI MEDICAL | ACS-789/120R ACS-789/120R | 2024-04-11 |
| DIXI MEDICAL | ACS-789/82R ACS-789/82R | 2024-04-11 |
| DIXI MEDICAL | MM08-06B51P12 MM08-06B51P12 | 2023-04-11 |
| DIXI MEDICAL | MM08-06B40P12 MM08-06B40P12 | 2023-04-11 |
| DIXI MEDICAL | MM08-06B33P12 MM08-06B33P12 | 2023-04-11 |
| DIXI MEDICAL | ACS-140SMS-10 ACS-140SMS-10 | 2022-10-18 |
| DIXI MEDICAL | ACS-040SMS-10 ACS-040SMS-10 | 2022-10-18 |
| DIXI MEDICAL | ACS-135SMS-10 ACS-135SMS-10 | 2022-10-18 |
| DIXI MEDICAL | ACS-130SMS-10 ACS-130SMS-10 | 2022-10-18 |
| DIXI MEDICAL | ACS-125SMS-10 ACS-125SMS-10 | 2022-10-18 |
| DIXI MEDICAL | CBL-09/300 CBL-09/300 | 2022-07-14 |
| DIXI MEDICAL | CBL-09/180 CBL-09/180 | 2022-07-14 |
| DIXI MEDICAL | CBL-09/150 CBL-09/150 | 2022-07-14 |
| DIXI MEDICAL | CBL-09/120 CBL-09/120 | 2022-07-14 |
| DIXI MEDICAL | CBL-06/300 CBL-06/300 | 2022-07-14 |
| DIXI MEDICAL | CBL-06/180 CBL-06/180 | 2022-07-14 |
| DIXI MEDICAL | CBL-06/150 CBL-06/150 | 2022-07-14 |
| DIXI MEDICAL | CBL-06/120 CBL-06/120 | 2022-07-14 |
| DIXI MEDICAL | KIP-ACS-515B KIP-ACS-515B | 2022-04-12 |
| DIXI MEDICAL | C10-16AIOM C10-16AIOM | 2022-01-10 |
| DIXI MEDICAL | C10-12BIOM C10-12BIOM | 2022-01-10 |
| DIXI MEDICAL | C10-08CIOM C10-08CIOM | 2022-01-10 |
| DIXI MEDICAL | C10-08AIOM C10-08AIOM | 2022-01-10 |
| DIXI MEDICAL | C10-06BIOM C10-06BIOM | 2022-01-10 |
| DIXI MEDICAL | C10-04CIOM C10-04CIOM | 2022-01-10 |
| DIXI MEDICAL | ACS-SG1S-5 ACS-SG1S-5 | 2022-01-10 |
| DIXI MEDICAL | CMI-12 CMI-12 | 2022-01-10 |
| DIXI MEDICAL | MM08-09A51D08 MM08-09A51D08 | 2022-01-10 |
| DIXI MEDICAL | MM08-06B51D12 MM08-06B51D12 | 2022-01-10 |
| DIXI MEDICAL | MM08-09A40D08 MM08-09A40D08 | 2022-01-10 |
| DIXI MEDICAL | MM08-06B40D12 MM08-06B40D12 | 2022-01-10 |
| DIXI MEDICAL | MM08-09A33D08 MM08-09A33D08 | 2022-01-10 |
| DIXI MEDICAL | MM08-06B33D12 MM08-06B33D12 | 2022-01-10 |
| DIXI MEDICAL | C10-16CIOM C10-16CIOM | 2022-01-10 |
| DIXI MEDICAL | ACS-760 ACS-760 | 2022-01-10 |
Dixi Medical | DIXI Medical Microdeep Micro-Macro Depth Electrodes | 2021-11-18 |
Dixi Medical | Dixi Medical Intraoperative Subdural Electrodes (Strips And Grids) | 2021-10-02 |
| DIXI MEDICAL | CBL-18/180 CBL-18/180 | 2019-09-23 |
| DIXI MEDICAL | CBL-18/150 CBL-18/150 | 2019-09-23 |
| DIXI MEDICAL | CBL-18/120 CBL-18/120 | 2019-09-23 |
| DIXI MEDICAL | CBL-18/30 CBL-18/30 | 2019-09-23 |
| DIXI MEDICAL | CBL-15/300 CBL-15/300 | 2019-09-23 |
| DIXI MEDICAL | CBL-15/180 CBL-15/180 | 2019-09-23 |
| DIXI MEDICAL | CBL-15/150 CBL-15/150 | 2019-09-23 |
| DIXI MEDICAL | CBL-15/120 CBL-15/120 | 2019-09-23 |
| DIXI MEDICAL | CBL-15/30 CBL-15/30 | 2019-09-23 |
| DIXI MEDICAL | CBL-12/300 CBL-12/300 | 2019-09-23 |
| DIXI MEDICAL | CBL-12/180 CBL-12/180 | 2019-09-23 |
| DIXI MEDICAL | CBL-12/150 CBL-12/150 | 2019-09-23 |
| DIXI MEDICAL | CBL-12/120 CBL-12/120 | 2019-09-23 |
| DIXI MEDICAL | CBL-12/30 CBL-12/30 | 2019-09-23 |
| DIXI MEDICAL | CBL-10/300 CBL-10/300 | 2019-09-23 |
| DIXI MEDICAL | CBL-10/180 CBL-10/180 | 2019-09-23 |
| DIXI MEDICAL | CBL-10/150 CBL-10/150 | 2019-09-23 |
| DIXI MEDICAL | CBL-10/120 CBL-10/120 | 2019-09-23 |
| DIXI MEDICAL | CBL-10/30 CBL-10/30 | 2019-09-23 |
| DIXI MEDICAL | CBL-08/300 CBL-08/300 | 2019-09-23 |
| DIXI MEDICAL | CBL-08/180 CBL-08/180 | 2019-09-23 |
| DIXI MEDICAL | CBL-08/150 CBL-08/150 | 2019-09-23 |
| DIXI MEDICAL | CBL-08/120 CBL-08/120 | 2019-09-23 |
| DIXI MEDICAL | CBL-08/30 CBL-08/30 | 2019-09-23 |
| DIXI MEDICAL | CBL-05/300 CBL-05/300 | 2019-09-23 |
| DIXI MEDICAL | CBL-05/180 CBL-05/180 | 2019-09-23 |
| DIXI MEDICAL | CBL-05/150 CBL-05/150 | 2019-09-23 |
| DIXI MEDICAL | CBL-05/120 CBL-05/120 | 2019-09-23 |
| DIXI MEDICAL | CBL-05/30 CBL-05/30 | 2019-09-23 |
| DIXI MEDICAL | ACS-740 ACS-740 | 2019-09-23 |
| DIXI MEDICAL | ACS-715 ACS-715 | 2019-09-23 |
| DIXI MEDICAL | ACS-714 ACS-714 | 2019-09-23 |
| DIXI MEDICAL | ACS-745 ACS-745 | 2019-09-23 |
| DIXI MEDICAL | ACS-710 ACS-710 | 2019-09-23 |
| DIXI MEDICAL | ACS-711 ACS-711 | 2019-09-23 |
| DIXI MEDICAL | ACS-750 ACS-750 | 2019-09-23 |
| DIXI MEDICAL | ACS-751 ACS-751 | 2019-09-23 |
| DIXI MEDICAL | ACS-050S-5 ACS-050S-5 | 2019-09-23 |
| DIXI MEDICAL | ACS-035SMS-10 ACS-035SMS-10 | 2019-09-23 |
| DIXI MEDICAL | ACS-030SMS-10 ACS-030SMS-10 | 2019-09-23 |
| DIXI MEDICAL | ACS-025SMS-10 ACS-025SMS-10 | 2019-09-23 |
| DIXI MEDICAL | ACS-020SMS-10 ACS-020SMS-10 | 2019-09-23 |
| DIXI MEDICAL | ACS-015SMS-10 ACS-015SMS-10 | 2019-09-23 |
| DIXI MEDICAL | ACS-770S-10 ACS-770S-10 | 2019-09-23 |
| DIXI MEDICAL | ACS-789-ROSA ACS-789-ROSA | 2019-09-23 |
| DIXI MEDICAL | ACS-789/120 ACS-789/120 | 2019-09-23 |
| DIXI MEDICAL | ACS-1300 ACS-1300 | 2019-09-23 |
| DIXI MEDICAL | D08-18AT D08-18AT | 2019-09-23 |
| DIXI MEDICAL | D08-18AM D08-18AM | 2019-09-23 |
| DIXI MEDICAL | D08-15BT D08-15BT | 2019-09-23 |
| DIXI MEDICAL | D08-15BM D08-15BM | 2019-09-23 |
| DIXI MEDICAL | D08-18CT D08-18CT | 2019-09-23 |
| DIXI MEDICAL | D08-18CM D08-18CM | 2019-09-23 |
| DIXI MEDICAL | D08-15CT D08-15CT | 2019-09-23 |
| DIXI MEDICAL | D08-15CM D08-15CM | 2019-09-23 |
| DIXI MEDICAL | D08-15AT D08-15AT | 2019-09-23 |
| DIXI MEDICAL | D08-15AM D08-15AM | 2019-09-23 |
| DIXI MEDICAL | D08-12AT D08-12AT | 2019-09-23 |
| DIXI MEDICAL | D08-12AM D08-12AM | 2019-09-23 |
| DIXI MEDICAL | D08-10AT D08-10AT | 2019-09-23 |
| DIXI MEDICAL | D08-10AM D08-10AM | 2019-09-23 |
| DIXI MEDICAL | D08-08AT D08-08AT | 2019-09-23 |
| DIXI MEDICAL | D08-08AM D08-08AM | 2019-09-23 |
| DIXI MEDICAL | D08-05AT D08-05AT | 2019-09-23 |
| DIXI MEDICAL | D08-05AM D08-05AM | 2019-09-23 |
Mark LEMKO [DIXI Medical] | DIXI Medical Wrench | 2017-11-29 |
Mark LEMKO [DIXI Medical] | DIXI Medical Stylet | 2017-11-29 |
Mark LEMKO [DIXI Medical] | DIXI Medical Sliding Ruler | 2017-11-29 |
Mark LEMKO [DIXI Medical] | DIXI Medical Short Screwdriver | 2017-11-29 |
Mark LEMKO [DIXI Medical] | DIXI Medical Microdeep Depth Electrode | 2017-11-29 |
Mark LEMKO [DIXI Medical] | DIXI Medical Marking Rod | 2017-11-29 |
Mark LEMKO [DIXI Medical] | DIXI Medical Long Screwdriver | 2017-11-29 |
Mark LEMKO [DIXI Medical] | DIXI Medical Instrument Guide | 2017-11-29 |
Mark LEMKO [DIXI Medical] | DIXI Medical Flat Screwdriver | 2017-11-29 |
Mark LEMKO [DIXI Medical] | DIXI Medical Extension Cable | 2017-11-29 |
Mark LEMKO [DIXI Medical] | DIXI Medical Drill and Stop | 2017-11-29 |
Mark LEMKO [DIXI Medical] | DIXI Medical Depth Report Device | 2017-11-29 |
Mark LEMKO [DIXI Medical] | DIXI Medical Connection Cable | 2017-11-29 |
Mark LEMKO [DIXI Medical] | DIXI Medical Coagulation Electrode and Stop | 2017-11-29 |
Mark LEMKO [DIXI Medical] | DIXI Medical Cap for Anchor Bolt | 2017-11-29 |
Mark LEMKO [DIXI Medical] | DIXI Medical Bone Starter | 2017-11-29 |
Mark LEMKO [DIXI Medical] | DIXI Medical Anchor Bolt | 2017-11-29 |
Mark LEMKO [DIXI Medical] | DIXI Medical Adapter | 2017-11-29 |
DIXI Medical | DIXI Medical Microdeep Depth Electrode | 2017-11-24 |