FDA.reportPublic FDA data

GIVEN IMAGING LTD.

Matched from indexed company URL: Given Imaging, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
97101073003348376GIVEN IMAGING LTD.1N2026-01-012 Hacarmel St. NEW INDUSTRIAL Park, POB 258 Yoqneam Northern IL 2069204
30076629583007662958Given Imaging Vietnam Co., Ltd.1N2026-01-01Suite 6A, 6 floor, Standard Factory Bldg., 14th Street Tan Thuan EPZ, Tan Thuan Dong Ward Ho Chi Minh City VN District 7
30031416353003141635GIVEN IMAGING INC.1Y2020-04-2515 Hampshire Street Mansfield MA US 02048
30053442233005344223Given Imaging Los Angeles1Y2020-04-255860 Uplander Way Culver City Culver City CA US 90230
30160990703016099070Given Imaging Ltd1N2020-04-257 Hamarpe St.P.O. Box 45025 Jerusalem Yerushalayim IL 9777407

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04260167480954ManoScan - AR 3D Probe+1(508)261-8000covidien.udi@covidien.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3321811519345671K240276PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareNEZ2024-05-10
3321811200810190K230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0ENEZ2023-06-30
3321811302954467K211684PillCam SB 3 capsule endoscopy system, PillCam Software 9.0ENEZ2021-08-27
3321811752001067K180171PillCam Patency SystemNSI2018-03-08
3321811510827414K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0NEZ2017-09-01
3321811054419567K153466PillCam COLON 2 Capsule Endoscopy SystemPGD2016-01-14
1371451911061517K151086ManoScan SystemFFX2016-04-28
3321781993921557K151086ManoScan SystemFFX2016-04-28
3321811993921557K151086ManoScan SystemFFX2016-04-28
3321811280280542K140284GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEMNEZ2014-12-17
2355681370077878K123864GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEMNEZ2013-08-12
1371451370077878K123864GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEMNEZ2013-08-12
3321811967077710K123864GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEMNEZ2013-08-12
3321811088392787K102543BRAVO PH MONITORING SYSTEM AND ACCESSORIESFFT2010-12-01
3321811751524723K092342SMARTPILL GI MONITORING SYSTEM, VERSION 2.0NYV2009-10-30
3321781742569664K012891OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)DQA2002-03-07
1371451250935506
3321781319270287
3321811319270287

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NEZ82024-05-10
FFX32016-04-28
NSI12018-03-08
PGD12016-01-14
FFT12010-12-01
NYV12009-10-30
DQA12002-03-07

PMN#

GUDID#

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