Andrea Mitchell

FDA Filings

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

FDA Registration(s)
Registration Number3013060098
FEI Number3013060098
NameAndrea Mitchell
Owner & OperatorMedtronic
Contact Address16720 Trans-Canada, Suite 200
Kirkland CA-QC Quebec H9H 4M7 CA
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address15 Hampshire Street
Mansfield, MA 02048 US
Establishment TypeExport Device to the United States But Perform No Other Operation on Device



Registration Number9710107
FEI Number3003348376
NameAndrea Mitchell
Owner & OperatorGiven Imaging Inc.
Contact Address2 Hacarmel St., New Industrial Park, POB
Yoqneam IL-Z Ha Zafon 20692 IL
Official Correspondent
  • Hilla - Debby
  • 972-4-9097774-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address15 Hampshire Street
Mansfield, MA 02048 US
Establishment Type
  • Remanufacture Medical Device
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Andrea Mitchell [Given Imaging Inc.]
VS3 Iridium 785nm (VS3-IR-785) including MMS-IR and Endoscope-IR2020-02-26
Andrea Mitchell [Given Imaging Inc.]
VS3 Iridium 785nm (VS3-IR-785) including MMS-IR and Endoscope-IR2020-02-26
Andrea Mitchell [Given Imaging Inc.]
VS3 Iridium 785nm (VS3-IR-785) including MMS-IR and Endoscope-IR2020-02-26
Andrea Mitchell [Given Imaging Inc.]
VS3 Iridium 785nm (VS3-IR-785) including MMS-IR and Endoscope-IR2020-02-26
Andrea Mitchell [Given Imaging Inc.]
VS3 Iridium (VS3-IR) including MMS-IR and Endoscope-IR2020-02-26
Andrea Mitchell [Given Imaging Inc.]
VS3 Iridium (VS3-IR) including MMS-IR and Endoscope-IR2020-02-26
Andrea Mitchell [Given Imaging Inc.]
VS3 Iridium (VS3-IR) including MMS-IR and Endoscope-IR2020-02-26
Andrea Mitchell [Given Imaging Inc.]
VS3 Iridium (VS3-IR) including MMS-IR and Endoscope-IR2020-02-26
Andrea Mitchell [Given Imaging Inc.]
VS3 Iridium (VS3-IR-MMS) with MMS-IR Only2020-02-26
Andrea Mitchell [Given Imaging Inc.]
Patency Capsule2019-09-02
Andrea Mitchell [Given Imaging Inc.]
Patency Capsule2019-09-02
Andrea Mitchell [Given Imaging Inc.]
Patency Capsule2019-09-02
Andrea Mitchell [Medtronic]
Valleylab2019-04-08
Andrea Mitchell [Medtronic]
REM Polyhesive Neonatal Patient Return Electrode2019-04-08
Andrea Mitchell [Given Imaging Inc.]
PillCam software2017-11-16
Andrea Mitchell [Given Imaging Inc.]
PillCam endoscopy system2017-11-16
Andrea Mitchell [Given Imaging Inc.]
PillCam Crohn capsule2017-11-16
Andrea Mitchell [Given Imaging Inc.]
PillCam software2017-11-16
Andrea Mitchell [Given Imaging Inc.]
PillCam endoscopy system2017-11-16
Andrea Mitchell [Given Imaging Inc.]
PillCam Crohn capsule2017-11-16
Andrea Mitchell [Given Imaging Inc.]
ManoView ESO sw2016-07-19
Andrea Mitchell [Given Imaging Inc.]
ManoView AR sw2016-07-19
Andrea Mitchell [Given Imaging Inc.]
ManoShield (disposable sanitary sheaths)2016-07-19
Andrea Mitchell [Given Imaging Inc.]
ManoScan sw2016-07-19
Andrea Mitchell [Given Imaging Inc.]
ManoScan base pressure module ( A120)2016-07-19
Andrea Mitchell [Given Imaging Inc.]
ManoScan System2016-07-19
Andrea Mitchell [Given Imaging Inc.]
ManoScan Impedance module (Z) A2002016-07-19
Andrea Mitchell [Given Imaging Inc.]
ManoScan 3D HRM A300 module2016-07-19
Andrea Mitchell [Given Imaging Inc.]
Disposable Balloons2016-07-19
Andrea Mitchell [Given Imaging Inc.]
RAPID Software2016-01-18
Andrea Mitchell [Given Imaging Inc.]
PillCam COLON 2 Capsule2016-01-18
Andrea Mitchell [Given Imaging Inc.]
Endoscopy System2016-01-18
Andrea Mitchell [Given Imaging Inc.]
RAPID 82015-01-05
Andrea Mitchell [Given Imaging Inc.]
PillCam UGI Capsule2015-01-05
Andrea Mitchell [Given Imaging Inc.]
DR32015-01-05
Andrea Mitchell [Given Imaging Inc.]
Accessories2015-01-05
Andrea Mitchell [Given Imaging Inc.]
RAPID 82015-01-05
Andrea Mitchell [Given Imaging Inc.]
PillCam UGI Capsule2015-01-05
Andrea Mitchell [Given Imaging Inc.]
DR32015-01-05
Andrea Mitchell [Given Imaging Inc.]
Accessories2015-01-05
Andrea Mitchell [Given Imaging Inc.]
SB 32013-08-15
Andrea Mitchell [Given Imaging Inc.]
Reflux and AccuView software2013-07-24
Andrea Mitchell [Given Imaging Inc.]
Bravo? Reflux Capsule with Delivery Device2013-07-24
Andrea Mitchell [Given Imaging Inc.]
Bravo? CF reflux recorder2013-07-24
Andrea Mitchell [Given Imaging Inc.]
Bravo pH Recorder2013-07-24
Andrea Mitchell [Given Imaging Inc.]
Bravo pH Delivery System Accessories2013-07-24
Andrea Mitchell [Given Imaging Inc.]
Bravo pH Capsule with Delivery Device2013-07-24
Andrea Mitchell [Given Imaging Inc.]
Bravo System2013-07-24
Andrea Mitchell [Given Imaging Inc.]
SmartPill pH.p Capsule2012-10-31
Andrea Mitchell [Given Imaging Inc.]
SmartPill MotiliGI Software2012-10-31
Andrea Mitchell [Given Imaging Inc.]
SmartPill GI Monitoring System, version 2.02012-10-31
Andrea Mitchell [Given Imaging Inc.]
SmartPill Docking Station2012-10-31
Andrea Mitchell [Given Imaging Inc.]
SmartPill Data Receiver2012-10-31
Andrea Mitchell [Given Imaging Inc.]
SmartPill Capsule Calibration Fluid2012-10-31
Andrea Mitchell [Given Imaging Inc.]
Activation Fixture2012-10-31
Andrea Mitchell [Given Imaging Inc.]
pHersaflex pH catheters2012-01-09
Andrea Mitchell [Given Imaging Inc.]
Versaflex pH catheters2012-01-09
Andrea Mitchell [Given Imaging Inc.]
Versaflex pH Z catheters2012-01-09
Andrea Mitchell [Given Imaging Inc.]
Reflux software2012-01-09
Andrea Mitchell [Given Imaging Inc.]
Digitrapper pH Z2012-01-09
Andrea Mitchell [Given Imaging Inc.]
AccuView pH & pH-Z software2012-01-09

Similar & Related FDA Registered Companies

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020060159654Yantian,China (Mainland) -> Oakland, CaliforniaNAIL GLUE NAIL GLUE1 PCS
20200501119610Yantian,China (Mainland) -> Oakland, CaliforniaJEANS1 PCS
2019120778935Halifax, NS,Canada -> West Palm Beach, FloridaPASTA , GRAINS , FLOUR , RICE , CLOTHING1 BBL

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