Data / Medical devices / Israel / Given Imaging Ltd.

Given Imaging Ltd.: FDA-registered device maker in Yoqneam Northern, Israel, 11 510(k) clearances

Name: Given Imaging Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Given Imaging Ltd. is registered with the FDA (registration 9710107) in Yoqneam Northern, Israel. It lists 6 device types. The FDA files 11 510(k) clearances under its listings, the newest dated May 10, 2024. 2 recall events name it as the recalling firm (2 Class I). Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Given Imaging Ltd.

FDA registration number: 9710107
FEI number: 3003348376
Address: 2 Hacarmel St. NEW INDUSTRIAL Park, POB 258, Yoqneam Northern, Israel, 2069204
Owner or operator: GIVEN IMAGING INC. (10091555)
Roles: Manufacturer
First device listed: October 15, 2024
Registered through: 2027
Brand names listed: Accessories, AccuView pH & pH-Z software, Activation Fixture, Bravo System, Bravo CF reflux recorder, Bravo Reflux Capsule with Delivery Device, DR3, Digitrapper pH Z and more

Devices it lists

Device	Product code	Class	Role	Source
Colon Capsule Imaging System	PGD	2	Manufacturer	accessdata.fda.gov
Electrode, Ph, Stomach	FFT	1	Manufacturer	accessdata.fda.gov
Gastrointestinal Motility System, Capsule	NYV	2	Manufacturer	accessdata.fda.gov
System, Gastrointestinal Motility (Electrical)	FFX	2	Manufacturer	accessdata.fda.gov
System, Imaging, Esophageal, Wireless, Capsule	NSI	2	Manufacturer	accessdata.fda.gov
System, Imaging, Gastrointestinal, Wireless, Capsule	NEZ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 10, 2024	K240276	PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software	NEZ	Substantially Equivalent	Given Imaging Ltd. (D.B.A. Medtronic)	accessdata.fda.gov
June 30, 2023	K230991	PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E	NEZ	Substantially Equivalent	Given Imaging Ltd. (Medtronic)	accessdata.fda.gov
August 27, 2021	K211684	PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E	NEZ	Substantially Equivalent	Given Imaging Ltd. (Medtronic)	accessdata.fda.gov
March 8, 2018	K180171	PillCam Patency System	NSI	Substantially Equivalent	Given Imaging , Ltd.	accessdata.fda.gov
September 1, 2017	K170210	PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0	NEZ	Substantially Equivalent	Given Imaging , Ltd.	accessdata.fda.gov
April 28, 2016	K151086	ManoScan System	FFX	Substantially Equivalent	Given Imaging , Ltd.	accessdata.fda.gov
January 14, 2016	K153466	PillCam COLON 2 Capsule Endoscopy System	PGD	Substantially Equivalent	Given Imaging , Ltd.	accessdata.fda.gov
December 17, 2014	K140284	GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM	NEZ	Substantially Equivalent	Given Imaging , Ltd.	accessdata.fda.gov
August 12, 2013	K123864	GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM	NEZ	Substantially Equivalent	Given Imaging , Ltd.	accessdata.fda.gov
December 1, 2010	K102543	BRAVO PH MONITORING SYSTEM AND ACCESSORIES	FFT	Substantially Equivalent	Given Imaging , Ltd.	accessdata.fda.gov
October 30, 2009	K092342	SMARTPILL GI MONITORING SYSTEM, VERSION 2.0	NYV	Substantially Equivalent	The Smartpill Corporation	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 6, 2026	99626	Class I	Ongoing	Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach a pH monitoring capsule to the esophagus.	Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.	accessdata.fda.gov
June 3, 2025	97029	Class I	Ongoing	Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)	It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device.	accessdata.fda.gov

Compare with other makers

Updated September 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.