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Eitan Medical LTD: FDA-registered device maker in Netanya Central, Israel, 6 510(k) clearances

Name: Eitan Medical LTD FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Eitan Medical LTD is registered with the FDA (registration 3010293992) in Netanya Central, Israel. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 10, 2023. 1 recall event names it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3010293992
Address: 29 Yad Haruzim St., Netanya Central, Israel, 4250529
Owner or operator: Eitan Medical LTD (10045422)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: November 14, 2013
Registered through: 2027
Brand names listed: Administration Sets and Accessories, Avoset Cassette lock, Avoset Cradle, Avoset infusion pump, Back Check Valve Set, Cartridge Set, Enteral Set, Epidural Set and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Pump, Infusion	MRZ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Pump, Infusion	FRN	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Complaint file establishment, Manufacturer, Specification developer	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
March 10, 2023	K213744	Avoset Infusion Pump System	FRN	Substantially Equivalent	Eitan Medical , Ltd.	accessdata.fda.gov
November 19, 2020	K192860	Sapphire Infusion Pump, Sapphire administration sets	FRN	Substantially Equivalent	Q Core Medical , Ltd.	accessdata.fda.gov
March 27, 2017	K161667	Sapphire Infusion Pump	FRN	Substantially Equivalent	Q Core Medical , Ltd.	accessdata.fda.gov
December 11, 2014	K141389	SAPPHIRE INFUSION PUMP	FRN	Substantially Equivalent	Q Core Medical , Ltd.	accessdata.fda.gov
August 5, 2014	K141834	SAPPHIRE ADMINISTRATION SET	FPA	Substantially Equivalent	Q Core Medical , Ltd.	accessdata.fda.gov
October 17, 2013	K123049	SAPPHIRE INFUSION PUMP	FRN	Substantially Equivalent	Q Core Medical , Ltd.	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
September 11, 2023	93105	Class I	Ongoing	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.	accessdata.fda.gov

Compare with other makers

Updated October 20, 2023. 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.