Given Imaging , Ltd.

FDA 510(k) & PMA Approved Devices — 27 products

Total Devices27

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K180171	PillCam Patency System	NSI	2018-03-08	View
510(k)	K170210	PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0	NEZ	2017-09-01	View
510(k)	K170839	RAPID Web	NEZ	2017-05-26	View
510(k)	K151086	ManoScan System	FFX	2016-04-28	View
510(k)	K153466	PillCam COLON 2 Capsule Endoscopy System	PGD	2016-01-14	View
510(k)	K123864	GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM	NEZ	2013-08-12	View
510(k)	K103025	GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES	NEZ	2011-05-13	View
510(k)	K101250	GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES	NEZ	2011-03-07	View
510(k)	K103088	GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT	NEZ	2011-01-14	View
510(k)	K102543	BRAVO PH MONITORING SYSTEM AND ACCESSORIES	FFT	2010-12-01	View
510(k)	K101200	PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE	NEZ	2010-09-30	View
510(k)	K090557	GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM	NSI	2009-09-28	View
510(k)	K091405	PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT	NEZ	2009-07-29	View
510(k)	K071153	GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE	NSI	2007-06-11	View
510(k)	K070475	MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM	NEZ	2007-05-07	View
510(k)	K062786	MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM	NEZ	2006-10-18	View
510(k)	K060805	MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM	NSI	2006-05-24	View
510(k)	K053639	GIVEN DIAGNOSTIC SYSTEM	NEZ	2006-05-08	View
510(k)	K052184	GIVEN DIAGNOSTIC SYSTEM	NSI	2005-12-01	View
510(k)	K042960	GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO	NSI	2004-11-24	View