Dixi Medical

FDA Filings

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.

FDA Registration(s)
Registration Number3014527920
FEI Number3014527920
NameDIXI MEDICAL USA
Owner & OperatorDIXI Medical
Contact Address2A ROUTE DE POULIGNEY
CHAUDEFONTAINE FR-25 Doubs 25640 FR
Official Correspondent
  • Lucie PETEGNIEF
  • 033-3-81889890-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address11910 Fox Ridge Drive
Plymouth, MI 48170 US



Registration Number3007636029
FEI Number3007636029
NameMark LEMKO
Owner & OperatorDIXI Medical
Contact Address2A ROUTE DE POULIGNEY
CHAUDEFONTAINE FR-25 Doubs 25640 FR
Official Correspondent
  • Lucie PETEGNIEF
  • 033-3-81889890-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address11910 FOX RIDGE DRIVE
Plymouth, MI 48170 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Dixi Medical
Dixi Medical Intraoperative Subdural Electrodes (Strips And Grids)2021-10-02
DIXI MEDICAL
KIP-ACS-605 KIP-ACS-6052019-09-23
DIXI MEDICAL
KIP-ACS-600 KIP-ACS-6002019-09-23
DIXI MEDICAL
KIP-ACS-519 KIP-ACS-5192019-09-23
DIXI MEDICAL
KIP-ACS-518 KIP-ACS-5182019-09-23
DIXI MEDICAL
KIP-ACS-517 KIP-ACS-5172019-09-23
DIXI MEDICAL
KIP-ACS-516 KIP-ACS-5162019-09-23
DIXI MEDICAL
KIP-ACS-515 KIP-ACS-5152019-09-23
DIXI MEDICAL
KIP-ACS-513 KIP-ACS-5132019-09-23
DIXI MEDICAL
KIP-ACS-512 KIP-ACS-5122019-09-23
DIXI MEDICAL
KIP-ACS-511 KIP-ACS-5112019-09-23
DIXI MEDICAL
KIP-ACS-510 KIP-ACS-5102019-09-23
DIXI MEDICAL
ADP-05 ADP-052019-09-23
DIXI MEDICAL
ADP-08 ADP-082019-09-23
DIXI MEDICAL
ADP-10 ADP-102019-09-23
DIXI MEDICAL
ADP-12 ADP-122019-09-23
DIXI MEDICAL
ADP-15 ADP-152019-09-23
DIXI MEDICAL
ADP-18 ADP-182019-09-23
DIXI MEDICAL
PCP-18A/300 PCP-18A/3002019-09-23
DIXI MEDICAL
PCP-18A/90 PCP-18A/902019-09-23
DIXI MEDICAL
PCP-18/300 PCP-18/3002019-09-23
DIXI MEDICAL
PCP-18/90 PCP-18/902019-09-23
DIXI MEDICAL
CBL-18/300 CBL-18/3002019-09-23
DIXI MEDICAL
CBL-18/180 CBL-18/1802019-09-23
DIXI MEDICAL
CBL-18/150 CBL-18/1502019-09-23
DIXI MEDICAL
CBL-18/120 CBL-18/1202019-09-23
DIXI MEDICAL
CBL-18/30 CBL-18/302019-09-23
DIXI MEDICAL
CBL-15/300 CBL-15/3002019-09-23
DIXI MEDICAL
CBL-15/180 CBL-15/1802019-09-23
DIXI MEDICAL
CBL-15/150 CBL-15/1502019-09-23
DIXI MEDICAL
CBL-15/120 CBL-15/1202019-09-23
DIXI MEDICAL
CBL-15/30 CBL-15/302019-09-23
DIXI MEDICAL
CBL-12/300 CBL-12/3002019-09-23
DIXI MEDICAL
CBL-12/180 CBL-12/1802019-09-23
DIXI MEDICAL
CBL-12/150 CBL-12/1502019-09-23
DIXI MEDICAL
CBL-12/120 CBL-12/1202019-09-23
DIXI MEDICAL
CBL-12/30 CBL-12/302019-09-23
DIXI MEDICAL
CBL-10/300 CBL-10/3002019-09-23
DIXI MEDICAL
CBL-10/180 CBL-10/1802019-09-23
DIXI MEDICAL
CBL-10/150 CBL-10/1502019-09-23
DIXI MEDICAL
CBL-10/120 CBL-10/1202019-09-23
DIXI MEDICAL
CBL-10/30 CBL-10/302019-09-23
DIXI MEDICAL
CBL-08/300 CBL-08/3002019-09-23
DIXI MEDICAL
CBL-08/180 CBL-08/1802019-09-23
DIXI MEDICAL
CBL-08/150 CBL-08/1502019-09-23
DIXI MEDICAL
CBL-08/120 CBL-08/1202019-09-23
DIXI MEDICAL
CBL-08/30 CBL-08/302019-09-23
DIXI MEDICAL
CBL-05/300 CBL-05/3002019-09-23
DIXI MEDICAL
CBL-05/180 CBL-05/1802019-09-23
DIXI MEDICAL
CBL-05/150 CBL-05/1502019-09-23
DIXI MEDICAL
CBL-05/120 CBL-05/1202019-09-23
DIXI MEDICAL
CBL-05/30 CBL-05/302019-09-23
DIXI MEDICAL
ACS-740 ACS-7402019-09-23
DIXI MEDICAL
ACS-715 ACS-7152019-09-23
DIXI MEDICAL
ACS-714 ACS-7142019-09-23
DIXI MEDICAL
ACS-745 ACS-7452019-09-23
DIXI MEDICAL
ACS-710 ACS-7102019-09-23
DIXI MEDICAL
ACS-711 ACS-7112019-09-23
DIXI MEDICAL
ACS-750 ACS-7502019-09-23
DIXI MEDICAL
ACS-751 ACS-7512019-09-23
DIXI MEDICAL
ACS-050S-5 ACS-050S-52019-09-23
DIXI MEDICAL
ACS-035SMS-10 ACS-035SMS-102019-09-23
DIXI MEDICAL
ACS-030SMS-10 ACS-030SMS-102019-09-23
DIXI MEDICAL
ACS-025SMS-10 ACS-025SMS-102019-09-23
DIXI MEDICAL
ACS-020SMS-10 ACS-020SMS-102019-09-23
DIXI MEDICAL
ACS-015SMS-10 ACS-015SMS-102019-09-23
DIXI MEDICAL
ACS-770S-10 ACS-770S-102019-09-23
DIXI MEDICAL
ACS-789-ROSA ACS-789-ROSA2019-09-23
DIXI MEDICAL
ACS-789/120 ACS-789/1202019-09-23
DIXI MEDICAL
ACS-1300 ACS-13002019-09-23
DIXI MEDICAL
D08-18AT D08-18AT2019-09-23
DIXI MEDICAL
D08-18AM D08-18AM2019-09-23
DIXI MEDICAL
D08-15BT D08-15BT2019-09-23
DIXI MEDICAL
D08-15BM D08-15BM2019-09-23
DIXI MEDICAL
D08-18CT D08-18CT2019-09-23
DIXI MEDICAL
D08-18CM D08-18CM2019-09-23
DIXI MEDICAL
D08-15CT D08-15CT2019-09-23
DIXI MEDICAL
D08-15CM D08-15CM2019-09-23
DIXI MEDICAL
D08-15AT D08-15AT2019-09-23
DIXI MEDICAL
D08-15AM D08-15AM2019-09-23
DIXI MEDICAL
D08-12AT D08-12AT2019-09-23
DIXI MEDICAL
D08-12AM D08-12AM2019-09-23
DIXI MEDICAL
D08-10AT D08-10AT2019-09-23
DIXI MEDICAL
D08-10AM D08-10AM2019-09-23
DIXI MEDICAL
D08-08AT D08-08AT2019-09-23
DIXI MEDICAL
D08-08AM D08-08AM2019-09-23
DIXI MEDICAL
D08-05AT D08-05AT2019-09-23
DIXI MEDICAL
D08-05AM D08-05AM2019-09-23
Mark LEMKO [DIXI Medical]
DIXI Medical Wrench2017-11-29
Mark LEMKO [DIXI Medical]
DIXI Medical Stylet2017-11-29
Mark LEMKO [DIXI Medical]
DIXI Medical Sliding Ruler2017-11-29
Mark LEMKO [DIXI Medical]
DIXI Medical Short Screwdriver2017-11-29
Mark LEMKO [DIXI Medical]
DIXI Medical Microdeep Depth Electrode2017-11-29
Mark LEMKO [DIXI Medical]
DIXI Medical Marking Rod2017-11-29
Mark LEMKO [DIXI Medical]
DIXI Medical Long Screwdriver2017-11-29
Mark LEMKO [DIXI Medical]
DIXI Medical Instrument Guide2017-11-29
Mark LEMKO [DIXI Medical]
DIXI Medical Flat Screwdriver2017-11-29
Mark LEMKO [DIXI Medical]
DIXI Medical Extension Cable2017-11-29
Mark LEMKO [DIXI Medical]
DIXI Medical Drill and Stop2017-11-29
Mark LEMKO [DIXI Medical]
DIXI Medical Depth Report Device2017-11-29
Mark LEMKO [DIXI Medical]
DIXI Medical Connection Cable2017-11-29
Mark LEMKO [DIXI Medical]
DIXI Medical Coagulation Electrode and Stop2017-11-29
Mark LEMKO [DIXI Medical]
DIXI Medical Cap for Anchor Bolt2017-11-29
Mark LEMKO [DIXI Medical]
DIXI Medical Bone Starter2017-11-29
Mark LEMKO [DIXI Medical]
DIXI Medical Anchor Bolt2017-11-29
Mark LEMKO [DIXI Medical]
DIXI Medical Adapter2017-11-29
DIXI Medical
DIXI Medical Microdeep Depth Electrode2017-11-24

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