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:
| Registration Number | 3008487708 | ||||||||
| FEI Number | 3008487708 | ||||||||
| Name | KOELIS | ||||||||
| Owner & Operator | KOELIS | ||||||||
| Contact Address | 16 Chemin du vieux chene MEYLAN FR-38 Isere 38240 FR | ||||||||
| Official Correspondent |
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| US Agent |
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| Importing Logistics Registration |
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| Importing Logistics Registration |
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| Registration Status | 1 | ||||||||
| Initial Importer | N | ||||||||
| Registration Expiration | 2020-04-25 | ||||||||
| Registration Address | 16 Chemin du Vieux Chene MEYLAN Isere, 38240 FR | ||||||||
| Establishment Type |
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Device Company | Device | Date |
|---|---|---|
| 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-XX | 2019-10-07 |
KOELIS | Disposable Guide | 2018-07-19 |
Koelis | Disposable Guides KDNG00 | 2018-07-10 |
KOELIS | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range | 2017-08-25 |
KOELIS | TRINITY/3D PROSTATE SUITE | 2017-08-18 |
KOELIS | TRINITY/3D PROSTATE SUITE | 2017-08-18 |
KOELIS | TRINITY/3D PROSTATE SUITE | 2017-08-18 |
KOELIS | TRINITY/3D PROSTATE SUITE | 2017-08-18 |
Koelis | Reusable Guides Ranges (PERINE Range, NAIL Range, CON-LEAD Range And LIN-LEAD Range) And STEADY PRO Range | 2017-07-31 |
KOELIS | TRINITY/3D PROSTATE SUITE | 2017-05-30 |
KOELIS | TRINITY KURO-3000 | 2016-05-18 |
KOELIS | PROMAP 3D PROSTATE SUITE KSOF-2602 | 2016-05-18 |
KOELIS | 2D/3D ENDOCAVITARY END FIRE PROBE K3DEC00 | 2016-05-18 |
KOELIS | 2D LINEAR PROBE K2DLN00 | 2016-05-18 |
KOELIS | 2D ABDOMINAL PROBE K2DAB00 | 2016-05-18 |
KOELIS | TRINITY KURO-3000 | 2016-05-18 |
KOELIS | PROMAP 3D PROSTATE SUITE KSOF-2602 | 2016-05-18 |
KOELIS | 2D/3D ENDOCAVITARY END FIRE PROBE K3DEC00 | 2016-05-18 |
KOELIS | 2D LINEAR PROBE K2DLN00 | 2016-05-18 |
KOELIS | 2D ABDOMINAL PROBE K2DAB00 | 2016-05-18 |
KOELIS | TRINITY KURO-3000 | 2016-05-18 |
KOELIS | PROMAP 3D PROSTATE SUITE KSOF-2602 | 2016-05-18 |
KOELIS | 2D/3D ENDOCAVITARY END FIRE PROBE K3DEC00 | 2016-05-18 |
KOELIS | 2D LINEAR PROBE K2DLN00 | 2016-05-18 |
KOELIS | 2D ABDOMINAL PROBE K2DAB00 | 2016-05-18 |
KOELIS | TRINITY KURO-3000 | 2016-05-18 |
KOELIS | PROMAP 3D PROSTATE SUITE KSOF-2602 | 2016-05-18 |
KOELIS | 2D/3D ENDOCAVITARY END FIRE PROBE K3DEC00 | 2016-05-18 |
KOELIS | 2D LINEAR PROBE K2DLN00 | 2016-05-18 |
KOELIS | 2D ABDOMINAL PROBE K2DAB00 | 2016-05-18 |
KOELIS | TRINITY | 2016-05-02 |
KOELIS | REUSABLE GUIDE | 2014-12-23 |
KOELIS | UROSTATION TOUCH | 2014-12-23 |
KOELIS | UROSTATION 3D PROSTATE SUITE | 2014-12-23 |
KOELIS | PROMAP | 2014-12-23 |
KOELIS | MR DRAW | 2014-12-23 |
KOELIS | REUSABLE GUIDE | 2014-07-11 |
KOELIS | 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION | 2013-07-26 |
KOELIS | KOELIS | 2010-10-20 |
KOELIS | UROSTATION 3D PROSTATE SUITE | 2010-09-22 |