Medical Device Manufacturer · IL , Ra'Ananna 43373

Given Imaging , Ltd. - FDA 510(k) Cleared Devices

30 submissions · 28 cleared · Since 2001
Official Website
30
Total
28
Cleared
2
Denied
FDA 510(k) Regulatory Record - Given Imaging , Ltd. Gastroenterology & Urology ✕
30 devices
1-12 of 30
Cleared Mar 08, 2018
PillCam Patency System
K180171 · NSI
Gastroenterology & Urology · 45d
Cleared Sep 01, 2017
PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0
K170210 · NEZ
Gastroenterology & Urology · 220d
Cleared May 26, 2017
RAPID Web
K170839 · NEZ
Gastroenterology & Urology · 66d
Cleared Apr 28, 2016
ManoScan System
K151086 · FFX
Gastroenterology & Urology · 372d
Cleared Jan 14, 2016
PillCam COLON 2 Capsule Endoscopy System
K153466 · PGD
Gastroenterology & Urology · 44d
Cleared Dec 17, 2014
GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM
K140284 · NEZ
Gastroenterology & Urology · 316d
Not Cleared Jan 29, 2014
GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM
DEN120023 · PGD
Gastroenterology & Urology · 426d
Cleared Aug 12, 2013
GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE...
K123864 · NEZ
Gastroenterology & Urology · 238d
Cleared May 13, 2011
GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM...
K103025 · NEZ
Gastroenterology & Urology · 213d
Cleared Mar 07, 2011
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES
K101250 · NEZ
Gastroenterology & Urology · 307d
Cleared Jan 14, 2011
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT
K103088 · NEZ
Gastroenterology & Urology · 87d
Cleared Dec 01, 2010
BRAVO PH MONITORING SYSTEM AND ACCESSORIES
K102543 · FFT
Gastroenterology & Urology · 89d
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