This page includes the latest FDA filings for Given Imaging Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Given Imaging Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 3003141635 |
| FEI Number | 3003141635 |
| Name | GIVEN IMAGING INC. |
| Owner & Operator | Given Imaging Inc. |
| Contact Address | 2 Hacarmel St., New Industrial Park, POB Yoqneam IL-Z Ha Zafon 20692 IL |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 15 Hampshire Street Mansfield, MA 02048 US |
| Registration Number | 3007662958 |
| FEI Number | 3007662958 |
| Name | Tim Thomas |
| Owner & Operator | Given Imaging Inc. |
| Contact Address | 2 Hacarmel St., New Industrial Park, POB Yoqneam IL-Z Ha Zafon 20692 IL |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 15 Hampshire St Mansfield, MA 02048 US |
| Establishment Type | Manufacture Medical Device |
| 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 |
|
| US Agent |
|
| 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 |
| Registration Number | 3005344223 |
| FEI Number | 3005344223 |
| Name | Given Imaging Los Angeles |
| Owner & Operator | Given Imaging Inc. |
| Contact Address | 2 Hacarmel St., New Industrial Park, POB Yoqneam IL-Z Ha Zafon 20692 IL |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 5860 Uplander Way Culver City Culver City, CA 90230 US |
| Establishment Type |
|
| Registration Number | 9710107 |
| FEI Number | 3003348376 |
| Name | Andrea Mitchell |
| Owner & Operator | Given Imaging Inc. |
| Contact Address | 2 Hacarmel St., New Industrial Park, POB Yoqneam IL-Z Ha Zafon 20692 IL |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 15 Hampshire Street Mansfield, MA 02048 US |
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
| Given Imaging, Inc. | PillCam Genius | 2024-12-09 |
| Given Imaging, Inc. | PillCam Genius | 2024-12-09 |
| Given Imaging, Inc. | PillCam | 2024-11-22 |
| Given Imaging, Inc. | PillCam | 2024-11-22 |
| Given Imaging, Inc. | PillCam Genius | 2024-11-22 |
Andrea Mitchell [Given Imaging Inc.] | VS3 Iridium 785nm (VS3-IR-785) including MMS-IR and Endoscope-IR | 2020-02-26 |
Andrea Mitchell [Given Imaging Inc.] | VS3 Iridium 785nm (VS3-IR-785) including MMS-IR and Endoscope-IR | 2020-02-26 |
Andrea Mitchell [Given Imaging Inc.] | VS3 Iridium 785nm (VS3-IR-785) including MMS-IR and Endoscope-IR | 2020-02-26 |
Andrea Mitchell [Given Imaging Inc.] | VS3 Iridium 785nm (VS3-IR-785) including MMS-IR and Endoscope-IR | 2020-02-26 |
Andrea Mitchell [Given Imaging Inc.] | VS3 Iridium (VS3-IR) including MMS-IR and Endoscope-IR | 2020-02-26 |
Andrea Mitchell [Given Imaging Inc.] | VS3 Iridium (VS3-IR) including MMS-IR and Endoscope-IR | 2020-02-26 |
Andrea Mitchell [Given Imaging Inc.] | VS3 Iridium (VS3-IR) including MMS-IR and Endoscope-IR | 2020-02-26 |
Andrea Mitchell [Given Imaging Inc.] | VS3 Iridium (VS3-IR) including MMS-IR and Endoscope-IR | 2020-02-26 |
Andrea Mitchell [Given Imaging Inc.] | VS3 Iridium (VS3-IR-MMS) with MMS-IR Only | 2020-02-26 |
| Given Imaging, Inc. | GIFD FGS-0671 | 2020-01-17 |
| Given Imaging, Inc. | ManoScan 800000 | 2019-11-08 |
| Given Imaging, Inc. | FGS-0558 FGS-0558 | 2019-11-08 |
| Given Imaging, Inc. | FGS-8014 FGS-8014 | 2019-11-08 |
| Given Imaging, Inc. | VersaFlex FGS-0538 | 2019-11-08 |
| Given Imaging, Inc. | 3282 3282 | 2019-11-08 |
| Given Imaging, Inc. | 4655 4655 | 2019-11-08 |
| Given Imaging, Inc. | 4450 4450 | 2019-11-08 |
| Given Imaging, Inc. | 3283 3283 | 2019-11-08 |
| Given Imaging, Inc. | ManoScan 4604 | 2019-11-08 |
| Given Imaging, Inc. | ManoScan 800002 | 2019-11-08 |
| Given Imaging, Inc. | Polygraf ID 9043G0133 | 2019-11-08 |
| Given Imaging, Inc. | Digitrapper 800004 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957980 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 955907 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957914 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957902 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957985 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex FGS-9000-20 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex FGS-9000-19 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex FGS-9000-18 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex FGS-9000-17 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex FGS-9000-16 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex FGS-9579-70S | 2019-11-08 |
| Given Imaging, Inc. | Versaflex FGS-9559-01S | 2019-11-08 |
| Given Imaging, Inc. | ManoScan RFG-3890-EAN | 2019-11-08 |
| Given Imaging, Inc. | ManoScan RFG-1286 | 2019-11-08 |
| Given Imaging, Inc. | ManoScan RFG-2192 | 2019-11-08 |
| Given Imaging, Inc. | ManoScan RFG-3886 | 2019-11-08 |
| Given Imaging, Inc. | ManoScan RFG-3887 | 2019-11-08 |
| Given Imaging, Inc. | ManoScan 1286 | 2019-11-08 |
| Given Imaging, Inc. | ManoScan 2192 | 2019-11-08 |
| Given Imaging, Inc. | ManoScan 2195 | 2019-11-08 |
| Given Imaging, Inc. | ManoScan 3886 | 2019-11-08 |
| Given Imaging, Inc. | ManoScan 3890 | 2019-11-08 |
| Given Imaging, Inc. | ManoScan 800015 | 2019-11-08 |
| Given Imaging, Inc. | ManoScan FGS-8001 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 900005 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 900004 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 900003 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957983 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957978 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957976 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957975 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957974 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957973 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957972 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957971 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957970 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957933 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957932 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957931 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957930 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957925 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957924 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957923 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957922 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 957900 | 2019-11-08 |
| Given Imaging, Inc. | Versaflex 955901 | 2019-11-08 |
| Given Imaging, Inc. | ManoScan 3887 | 2019-11-08 |
| Given Imaging, Inc. | ManoScan 3885 | 2019-11-08 |
Andrea Mitchell [Given Imaging Inc.] | Patency Capsule | 2019-09-02 |
Andrea Mitchell [Given Imaging Inc.] | Patency Capsule | 2019-09-02 |
Andrea Mitchell [Given Imaging Inc.] | Patency Capsule | 2019-09-02 |
| Given Imaging, Inc. | FGS-0493 FGS-0493 | 2018-10-08 |
| Given Imaging, Inc. | FGS-0303 FGS-0303 | 2018-10-01 |
| Given Imaging, Inc. | FGS-0302 FGS-0302 | 2018-10-01 |
| Given Imaging, Inc. | PillCam RFB-0154 | 2018-07-06 |
| Given Imaging, Inc. | RAPID FGS-0480-01 | 2018-07-06 |
| Given Imaging, Inc. | RAPID FGS-0479-01 | 2018-07-06 |
| Given Imaging, Inc. | RAPID RFB-0336 | 2018-07-06 |
| Given Imaging, Inc. | RAPID FGS-0487 | 2018-07-06 |
| Given Imaging, Inc. | RAPID FGS-0485 | 2018-07-06 |
| Given Imaging, Inc. | Pillcam FGS-0482 | 2018-07-06 |
| Given Imaging, Inc. | RAPID FGS-0472 | 2018-07-06 |
| Given Imaging, Inc. | Pillcam FGS-0279 | 2018-07-06 |
| Given Imaging, Inc. | PillCam FGS-0155 | 2018-07-06 |
| Given Imaging, Inc. | PillCam FGS-0154 | 2018-07-06 |
| Given Imaging, Inc. | Pillcam FGS-0325 | 2018-07-06 |
| Given Imaging, Inc. | RAPID FGS-0434 | 2018-07-06 |
| Given Imaging, Inc. | RAPID FGS-0396 | 2018-07-06 |
| Given Imaging, Inc. | RAPID FGS-0399 | 2018-07-06 |
| Given Imaging, Inc. | FGS-0268-J FGS-0268-J | 2018-07-06 |
| Given Imaging, Inc. | FGS-0193-J FGS-0193-J | 2018-07-06 |
| Given Imaging, Inc. | FGS-0272-J FGS-0272-J | 2018-07-06 |
Andrea Mitchell [Given Imaging Inc.] | PillCam software | 2017-11-16 |
Andrea Mitchell [Given Imaging Inc.] | PillCam endoscopy system | 2017-11-16 |
Andrea Mitchell [Given Imaging Inc.] | PillCam Crohn capsule | 2017-11-16 |
Andrea Mitchell [Given Imaging Inc.] | PillCam software | 2017-11-16 |
Andrea Mitchell [Given Imaging Inc.] | PillCam endoscopy system | 2017-11-16 |
Andrea Mitchell [Given Imaging Inc.] | PillCam Crohn capsule | 2017-11-16 |
Tim Thomas [Given Imaging Inc.] | ManoView ESO sw | 2016-07-19 |
Tim Thomas [Given Imaging Inc.] | ManoView AR sw | 2016-07-19 |
Tim Thomas [Given Imaging Inc.] | ManoShield (disposable sanitary sheaths) | 2016-07-19 |
Tim Thomas [Given Imaging Inc.] | ManoScan sw | 2016-07-19 |
Tim Thomas [Given Imaging Inc.] | ManoScan base pressure module ( A120) | 2016-07-19 |
Tim Thomas [Given Imaging Inc.] | ManoScan System | 2016-07-19 |
Tim Thomas [Given Imaging Inc.] | ManoScan Impedance module (Z) A200 | 2016-07-19 |
Tim Thomas [Given Imaging Inc.] | ManoScan 3D HRM A300 module | 2016-07-19 |
Tim Thomas [Given Imaging Inc.] | Disposable Balloons | 2016-07-19 |
Given Imaging Los Angeles [Given Imaging Inc.] | ManoView ESO sw | 2016-07-19 |
Given Imaging Los Angeles [Given Imaging Inc.] | ManoView AR sw | 2016-07-19 |
Given Imaging Los Angeles [Given Imaging Inc.] | ManoShield (disposable sanitary sheaths) | 2016-07-19 |
Given Imaging Los Angeles [Given Imaging Inc.] | ManoScan sw | 2016-07-19 |
Given Imaging Los Angeles [Given Imaging Inc.] | ManoScan base pressure module ( A120) | 2016-07-19 |
Given Imaging Los Angeles [Given Imaging Inc.] | ManoScan System | 2016-07-19 |
Given Imaging Los Angeles [Given Imaging Inc.] | ManoScan Impedance module (Z) A200 | 2016-07-19 |
Given Imaging Los Angeles [Given Imaging Inc.] | ManoScan 3D HRM A300 module | 2016-07-19 |
Given Imaging Los Angeles [Given Imaging Inc.] | Disposable Balloons | 2016-07-19 |
Andrea Mitchell [Given Imaging Inc.] | ManoView ESO sw | 2016-07-19 |
Andrea Mitchell [Given Imaging Inc.] | ManoView AR sw | 2016-07-19 |
Andrea Mitchell [Given Imaging Inc.] | ManoShield (disposable sanitary sheaths) | 2016-07-19 |
Andrea Mitchell [Given Imaging Inc.] | ManoScan sw | 2016-07-19 |
Andrea Mitchell [Given Imaging Inc.] | ManoScan base pressure module ( A120) | 2016-07-19 |
Andrea Mitchell [Given Imaging Inc.] | ManoScan System | 2016-07-19 |
Andrea Mitchell [Given Imaging Inc.] | ManoScan Impedance module (Z) A200 | 2016-07-19 |
Andrea Mitchell [Given Imaging Inc.] | ManoScan 3D HRM A300 module | 2016-07-19 |
Andrea Mitchell [Given Imaging Inc.] | Disposable Balloons | 2016-07-19 |
Andrea Mitchell [Given Imaging Inc.] | RAPID Software | 2016-01-18 |
Andrea Mitchell [Given Imaging Inc.] | PillCam COLON 2 Capsule | 2016-01-18 |
Andrea Mitchell [Given Imaging Inc.] | Endoscopy System | 2016-01-18 |
Andrea Mitchell [Given Imaging Inc.] | RAPID 8 | 2015-01-05 |
Andrea Mitchell [Given Imaging Inc.] | PillCam UGI Capsule | 2015-01-05 |
Andrea Mitchell [Given Imaging Inc.] | DR3 | 2015-01-05 |
Andrea Mitchell [Given Imaging Inc.] | Accessories | 2015-01-05 |
Andrea Mitchell [Given Imaging Inc.] | RAPID 8 | 2015-01-05 |
Andrea Mitchell [Given Imaging Inc.] | PillCam UGI Capsule | 2015-01-05 |
Andrea Mitchell [Given Imaging Inc.] | DR3 | 2015-01-05 |
Andrea Mitchell [Given Imaging Inc.] | Accessories | 2015-01-05 |
Given Imaging Ltd [Given Imaging Inc.] | SB 3 | 2013-08-15 |
Given Imaging Los Angeles [Given Imaging Inc.] | SB 3 | 2013-08-15 |
Andrea Mitchell [Given Imaging Inc.] | SB 3 | 2013-08-15 |
Andrea Mitchell [Given Imaging Inc.] | Reflux and AccuView software | 2013-07-24 |
Andrea Mitchell [Given Imaging Inc.] | Bravo? Reflux Capsule with Delivery Device | 2013-07-24 |
Andrea Mitchell [Given Imaging Inc.] | Bravo? CF reflux recorder | 2013-07-24 |
Andrea Mitchell [Given Imaging Inc.] | Bravo pH Recorder | 2013-07-24 |
Andrea Mitchell [Given Imaging Inc.] | Bravo pH Delivery System Accessories | 2013-07-24 |
Andrea Mitchell [Given Imaging Inc.] | Bravo pH Capsule with Delivery Device | 2013-07-24 |
Andrea Mitchell [Given Imaging Inc.] | Bravo System | 2013-07-24 |
Andrea Mitchell [Given Imaging Inc.] | SmartPill pH.p Capsule | 2012-10-31 |
Andrea Mitchell [Given Imaging Inc.] | SmartPill MotiliGI Software | 2012-10-31 |
Andrea Mitchell [Given Imaging Inc.] | SmartPill GI Monitoring System, version 2.0 | 2012-10-31 |
Andrea Mitchell [Given Imaging Inc.] | SmartPill Docking Station | 2012-10-31 |
Andrea Mitchell [Given Imaging Inc.] | SmartPill Data Receiver | 2012-10-31 |
Andrea Mitchell [Given Imaging Inc.] | SmartPill Capsule Calibration Fluid | 2012-10-31 |
Andrea Mitchell [Given Imaging Inc.] | Activation Fixture | 2012-10-31 |
Tim Thomas [Given Imaging Inc.] | pHersaflex pH catheters | 2012-01-09 |
Tim Thomas [Given Imaging Inc.] | Versaflex pH catheters | 2012-01-09 |
Tim Thomas [Given Imaging Inc.] | Versaflex pH Z catheters | 2012-01-09 |
Tim Thomas [Given Imaging Inc.] | Reflux software | 2012-01-09 |
Tim Thomas [Given Imaging Inc.] | Digitrapper pH Z | 2012-01-09 |
Tim Thomas [Given Imaging Inc.] | AccuView pH & pH-Z software | 2012-01-09 |
Given Imaging Los Angeles [Given Imaging Inc.] | pHersaflex pH catheters | 2012-01-09 |
Given Imaging Los Angeles [Given Imaging Inc.] | Versaflex pH catheters | 2012-01-09 |
Given Imaging Los Angeles [Given Imaging Inc.] | Versaflex pH Z catheters | 2012-01-09 |
Given Imaging Los Angeles [Given Imaging Inc.] | Reflux software | 2012-01-09 |
Given Imaging Los Angeles [Given Imaging Inc.] | Digitrapper pH Z | 2012-01-09 |
Given Imaging Los Angeles [Given Imaging Inc.] | AccuView pH & pH-Z software | 2012-01-09 |
Andrea Mitchell [Given Imaging Inc.] | pHersaflex pH catheters | 2012-01-09 |
Andrea Mitchell [Given Imaging Inc.] | Versaflex pH catheters | 2012-01-09 |
Andrea Mitchell [Given Imaging Inc.] | Versaflex pH Z catheters | 2012-01-09 |
Andrea Mitchell [Given Imaging Inc.] | Reflux software | 2012-01-09 |
Andrea Mitchell [Given Imaging Inc.] | Digitrapper pH Z | 2012-01-09 |
Andrea Mitchell [Given Imaging Inc.] | AccuView pH & pH-Z software | 2012-01-09 |
| NCAGE Code | 1YH71 | GIVEN IMAGING, INC. |
| CAGE Code | 1YH71 | GIVEN IMAGING, INC. |
| S.A.M. Registration | 1YH71 [90073722] | GIVEN IMAGING, INC. |