Given Imaging Los Angeles

FDA Filings

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

FDA Registration(s)

• 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:
  • Hilla - Debby
  • 972-4-9097774-x
• 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:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K151086 | FFX Given Imaging Los Angeles [Given Imaging Inc.]	ManoView ESO sw	2016-07-19
PMN K151086 | FFX Given Imaging Los Angeles [Given Imaging Inc.]	ManoView AR sw	2016-07-19
PMN K151086 | FFX Given Imaging Los Angeles [Given Imaging Inc.]	ManoShield (disposable sanitary sheaths)	2016-07-19
PMN K151086 | FFX Given Imaging Los Angeles [Given Imaging Inc.]	ManoScan sw	2016-07-19
PMN K151086 | FFX Given Imaging Los Angeles [Given Imaging Inc.]	ManoScan base pressure module ( A120)	2016-07-19
PMN K151086 | FFX Given Imaging Los Angeles [Given Imaging Inc.]	ManoScan System	2016-07-19
PMN K151086 | FFX Given Imaging Los Angeles [Given Imaging Inc.]	ManoScan Impedance module (Z) A200	2016-07-19
PMN K151086 | FFX Given Imaging Los Angeles [Given Imaging Inc.]	ManoScan 3D HRM A300 module	2016-07-19
PMN K151086 | FFX Given Imaging Los Angeles [Given Imaging Inc.]	Disposable Balloons	2016-07-19
PMN K123864 | NEZ Given Imaging Los Angeles [Given Imaging Inc.]	SB 3	2013-08-15
FFT Given Imaging Los Angeles [Given Imaging Inc.]	pHersaflex pH catheters	2012-01-09
FFT Given Imaging Los Angeles [Given Imaging Inc.]	Versaflex pH catheters	2012-01-09
FFT Given Imaging Los Angeles [Given Imaging Inc.]	Versaflex pH Z catheters	2012-01-09
FFT Given Imaging Los Angeles [Given Imaging Inc.]	Reflux software	2012-01-09
FFT Given Imaging Los Angeles [Given Imaging Inc.]	Digitrapper pH Z	2012-01-09
FFT Given Imaging Los Angeles [Given Imaging Inc.]	AccuView pH & pH-Z software	2012-01-09