GE Medical Systems, Israel Ltd.

Haifa, IL

GE Medical Systems, Israel Ltd. appears in FDA device records in Haifa, IL. FDA records list 2 510(k) clearances between 2014-10-10 and 2025-06-12, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 2 510(k) clearances for GE Medical Systems, Israel Ltd. between 2014 and 2025. The busiest year on record is 2014, with 1. The most recent is 2025, with 1.

Clearances by year, as a table

510(k) clearance decisions for GE Medical Systems, Israel Ltd., by decision year
Year	Clearances
2014	1
2025	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K251153	Aurora	KPS	Substantially Equivalent	2025-06-12
K142323	Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System	IYN	Substantially Equivalent	2014-10-10

Registered establishments

FDA registered establishments for GE Medical Systems, Israel Ltd., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
9615849	3002973981	GE Medical Systems, Israel Ltd.	Nativ Ha'or Street no. 1, Haifa 3508510 IL	2026	ITO ITX IYN IYO QIH

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2652-2023	Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system	Some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adjustment mechanism which can result in the Venue Go system detaching from the cart and falling.	Class II	2023-09-06	Open, Classified

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain