Eitan Medical Ltd

Netanya Central, IL

Eitan Medical LTD appears in FDA device records in Netanya Central, IL. FDA records list one 510(k) clearance, 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: 1
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 1 510(k) clearance for Eitan Medical Ltd in 2023.

Clearances by year, as a table

510(k) clearance decisions for Eitan Medical Ltd, by decision year
Year	Clearances
2023	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K213744	Avoset Infusion Pump System	FRN	Substantially Equivalent	2023-03-10

Registered establishments

FDA registered establishments for Eitan Medical Ltd, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3010293992	3010293992	Eitan Medical LTD	29 Yad Haruzim St., Netanya Central 4250529 IL	2026	FPA FRN MRZ

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-0094-2024	Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)	Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.	Class I	2023-09-11	Open, Classified

Verification record

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