Koelis

FDA Filings

This page includes the latest FDA filings for Koelis. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Koelis holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3008487708
FEI Number3008487708
NameKOELIS
Owner & OperatorKOELIS
Contact Address16 Chemin du vieux chene
MEYLAN FR-38 Isere 38240 FR
Official Correspondent
  • Antoine LEROY
  • 033-458-176811-x
US Agent
Importing Logistics Registration
ImporterKOELIS
Address5 avenue du Grand Sablon KOELIS
la tronche, 38700 FRANCE
Importer TypeManufacturer
SubdivisionFR-38
Importing Logistics Registration
ImporterKOELIS INC
Address185 Alewife Brook Parkway Suite #410
Cambridge, MA 02138 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address16 Chemin du Vieux Chene
MEYLAN Isere, 38240 FR
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
KOELIS
3D Side Fire Endocavity Probe 2024-08-07
KOELIS
Steady Pro 2024-06-11
KOELIS
MrDraw 2023-10-10
KOELIS
2D Linear Probe 2023-04-13
KOELIS
2D Abdominal Probe 2023-04-13
KOELIS
3D Side-Fire Endocavity Probe 2023-04-13
KOELIS
3D End-Fire Endocavity Probe 2023-04-13
KOELIS
LIN LEAD 14G 2023-04-13
KOELIS
LIN LEAD 18G 2023-04-13
KOELIS
CON LEAD 14G 2023-04-13
KOELIS
NAIL range 2023-04-12
KOELIS
NAIL range 2023-04-12
KOELIS
Steady Pro 2022-10-14
KOELIS
Steady Pro 2022-10-14
KOELIS
Steady Pro 2022-10-14
KOELIS
Steady Pro 2022-10-14
KOELIS
PROMAP – 3D PROSTATE SUITE 2022-07-29
KOELIS
TRINITY 2022-04-08
KOELIS
MR DRAW 2020-07-31
KOELIS
Steady Pro 2020-07-27
KOELIS
transP - Perine Adaptater 2020-07-27
KOELIS
transP - Reusable Guid Perine Nail 14G 2020-07-27
KOELIS
transP - perine full grid 18G 2020-07-27
KOELIS
transP - perine full grid 14G 2020-07-27
KOELIS
transP - Reusable Guid Perine Grid 18G 2020-07-27
KOELIS
Reusable guide 2020-07-27
KOELIS
TRINITY 2019-11-18
KOELIS
Disposable guide for 3D endocavity end-fire KDNG-XX2019-10-07
KOELIS
Disposable Guide2018-07-19
Koelis
Disposable Guides KDNG002018-07-10
KOELIS
Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range2017-08-25
KOELIS
TRINITY/3D PROSTATE SUITE2017-08-18
KOELIS
TRINITY/3D PROSTATE SUITE2017-08-18
KOELIS
TRINITY/3D PROSTATE SUITE2017-08-18
KOELIS
TRINITY/3D PROSTATE SUITE2017-08-18
Koelis
Reusable Guides Ranges (PERINE Range, NAIL Range, CON-LEAD Range And LIN-LEAD Range) And STEADY PRO Range2017-07-31
KOELIS
TRINITY/3D PROSTATE SUITE2017-05-30
KOELIS
TRINITY KURO-30002016-05-18
KOELIS
PROMAP 3D PROSTATE SUITE KSOF-26022016-05-18
KOELIS
2D/3D ENDOCAVITARY END FIRE PROBE K3DEC002016-05-18
KOELIS
2D LINEAR PROBE K2DLN002016-05-18
KOELIS
2D ABDOMINAL PROBE K2DAB002016-05-18
KOELIS
TRINITY KURO-30002016-05-18
KOELIS
PROMAP 3D PROSTATE SUITE KSOF-26022016-05-18
KOELIS
2D/3D ENDOCAVITARY END FIRE PROBE K3DEC002016-05-18
KOELIS
2D LINEAR PROBE K2DLN002016-05-18
KOELIS
2D ABDOMINAL PROBE K2DAB002016-05-18
KOELIS
TRINITY KURO-30002016-05-18
KOELIS
PROMAP 3D PROSTATE SUITE KSOF-26022016-05-18
KOELIS
2D/3D ENDOCAVITARY END FIRE PROBE K3DEC002016-05-18
KOELIS
2D LINEAR PROBE K2DLN002016-05-18
KOELIS
2D ABDOMINAL PROBE K2DAB002016-05-18
KOELIS
TRINITY KURO-30002016-05-18
KOELIS
PROMAP 3D PROSTATE SUITE KSOF-26022016-05-18
KOELIS
2D/3D ENDOCAVITARY END FIRE PROBE K3DEC002016-05-18
KOELIS
2D LINEAR PROBE K2DLN002016-05-18
KOELIS
2D ABDOMINAL PROBE K2DAB002016-05-18
KOELIS
TRINITY2016-05-02
KOELIS
REUSABLE GUIDE2014-12-23
KOELIS
UROSTATION TOUCH2014-12-23
KOELIS
UROSTATION 3D PROSTATE SUITE2014-12-23
KOELIS
PROMAP2014-12-23
KOELIS
MR DRAW2014-12-23
KOELIS
REUSABLE GUIDE2014-07-11
KOELIS
3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION2013-07-26
KOELIS
KOELIS2010-10-20
KOELIS
UROSTATION 3D PROSTATE SUITE2010-09-22

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