This page includes the latest FDA filings for Given Imaging L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3016099070 |
| FEI Number | 3016099070 |
| Name | Given Imaging Ltd |
| Owner & Operator | Given Imaging Inc. |
| Contact Address | 2 Hacarmel St., New Industrial Park, POB Yoqneam IL-Z Ha Zafon 20692 IL |
| Official Correspondent |
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| US Agent |
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| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 7 Hamarpe St.P.O. Box 45025 Jerusalem Yerushalayim, 9777407 IL |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
Given Imaging Ltd. | PillCam Patency System | 2018-03-08 |
Given Imaging Ltd. | PillCam SBC Capsule Endoscopy System, PilCam Desktop Software 9.0 | 2017-09-01 |
Given Imaging Ltd. | RAPID Web | 2017-05-26 |
GIVEN IMAGING LTD. | ManoScan System | 2016-04-28 |
GIVEN IMAGING LTD. | PillCam COLON 2 Capsule Endoscopy System | 2016-01-14 |
GIVEN IMAGING LTD. | GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM | 2014-12-17 |
Given Imaging Ltd [Given Imaging Inc.] | SB 3 | 2013-08-15 |
GIVEN IMAGING LTD. | GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM | 2013-08-12 |
GIVEN IMAGING LTD. | GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES | 2011-05-13 |
GIVEN IMAGING LTD. | GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES | 2011-03-07 |
GIVEN IMAGING LTD. | GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT | 2011-01-14 |
GIVEN IMAGING LTD. | BRAVO PH MONITORING SYSTEM AND ACCESSORIES | 2010-12-01 |
GIVEN IMAGING LTD. | PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE | 2010-09-30 |
GIVEN IMAGING LTD. | GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM | 2009-09-28 |
GIVEN IMAGING LTD. | PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT | 2009-07-29 |
GIVEN IMAGING LTD. | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE | 2007-06-11 |
GIVEN IMAGING LTD. | MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM | 2007-05-07 |
GIVEN IMAGING LTD. | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | 2006-10-18 |
GIVEN IMAGING LTD. | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | 2006-05-24 |
GIVEN IMAGING LTD. | GIVEN DIAGNOSTIC SYSTEM | 2006-05-08 |
GIVEN IMAGING LTD. | GIVEN DIAGNOSTIC SYSTEM | 2005-12-01 |
GIVEN IMAGING LTD. | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO | 2004-11-24 |
GIVEN IMAGING LTD. | GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE | 2004-10-25 |
GIVEN IMAGING LTD. | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | 2004-02-17 |
GIVEN IMAGING LTD. | GIVEN DIAGNOSTIC SYSTEM | 2003-10-29 |
GIVEN IMAGING LTD. | GIVEN DIAGNOSTIC SYSTEM | 2003-07-01 |
GIVEN IMAGING LTD. | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | 2003-02-27 |
GIVEN IMAGING LTD. | GIVEN DIAGNOSTICS SYSTEM | 2002-08-09 |
GIVEN IMAGING LTD. | GIVEN DIAGNOSTIC SYSTEM | 2002-05-02 |
| NCAGE Code | 2411A | GIVEN IMAGING LTD. |
| NCAGE Code | SCG02 | GIVEN IMAGING LTD. |
| CAGE Code | SCG02 | GIVEN IMAGING LTD. |
| CAGE Code | 2411A | GIVEN IMAGING LTD. |
| SEC | 0001126140 | GIVEN IMAGING LTD |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2019032851816 | Haifa,Israel -> New York/Newark Area, Newark, New Jersey | ENERGIZER 399ZGB ZERO MECURY HS CODE 850640 | 1 SKD |