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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 25 Results
ProductCode: NEZ Applicant: GIVEN IMAGING LTD. Decision Date To: 06/17/2024
 
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pillcam™ genius sb system with pillcam software v9.7 and pillcam cloud reader software Given Imaging Ltd. (d.b.a. Medtronic) K240276 05/10/2024
pillcam sb 3 capsule endoscopy system, pillcam software 9.0e Given Imaging Ltd. (Medtronic) K230991 06/30/2023
pillcam sb 3 capsule endoscopy system, pillcam software 9.0e Given Imaging Ltd. (Medtronic) K211684 08/27/2021
pillcam patency system Given Imaging Ltd. K180171 03/08/2018
pillcam sbc capsule endoscopy system, pilcam desktop software 9.0 Given Imaging Ltd. K170210 09/01/2017
rapid web Given Imaging Ltd. K170839 05/26/2017
given pillcam ugi capsule endoscopy system GIVEN IMAGING LTD. K140284 12/17/2014
given pillcam endoscopy system with rapid 8.0, given pillcam sb 3 capsule endoscopy system GIVEN IMAGING LTD. K123864 08/12/2013
given pillcam platform with rapid 6.5 / given pillcam platform with pillcam eso 3 capsules GIVEN IMAGING LTD. K103025 05/13/2011
given pillcam platform with pillcam sb capsules GIVEN IMAGING LTD. K101250 03/07/2011
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