Data / Medical devices / Israel / Waismed Ltd.

Waismed Ltd.: FDA-registered device maker in Rosh Haayin Central, Israel, 7 510(k) clearances

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

Waismed Ltd. is registered with the FDA (registration 9616791) in Rosh Haayin Central, Israel. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 22, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9616791
FEI number: 3001316486
Address: 10 Amal St. Afek Industrial Park, Rosh Haayin Central, Israel, 4809234
Owner or operator: Safeguard US Operating LLC (9024805)
Roles: Manufacturer, Repackager or relabeler
First device listed: February 4, 1999
Registered through: 2026
Brand names listed: B.I.G, B.I.G. Adult, B.I.G. Pediatric, GO-IO, NIO Adult, NIO Fixation, NIO Infant, NIO Pediatric and more

Devices it lists

Device	Product code	Class	Role	Source
Device, Intravascular Catheter Securement	KMK	1	Manufacturer	accessdata.fda.gov
Intravenous Extension Tubing Set	OJA	2	Repackager or relabeler	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Manufacturer	accessdata.fda.gov
Needle, Interosseous	MHC	2	Manufacturer	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	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
July 22, 2021	K211968	NIO+ Adult	FMI	Substantially Equivalent	Waismed, Ltd.	accessdata.fda.gov
October 7, 2019	K190538	NIO-I	FMI	Substantially Equivalent	Waismed, Ltd.	accessdata.fda.gov
June 23, 2016	K160805	NIO-P	FMI	Substantially Equivalent	Waismed, Ltd.	accessdata.fda.gov
August 28, 2014	K142086	NIO -INTRAOSSEOUS DEVICE	FMI	Substantially Equivalent	Waismed, Ltd.	accessdata.fda.gov
December 22, 2006	K062940	BONE INJECTION GUN (B.I.G.)	FMI	Substantially Equivalent	Waismed, Ltd.	accessdata.fda.gov
October 11, 2002	K022415	BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST	FMI	Substantially Equivalent	Waismed, Ltd.	accessdata.fda.gov
November 17, 1998	K981853	BONE INJECTION GUN (B.I.G.) DEVICE	FMI	Substantially Equivalent	Waismed, 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
June 5, 2025	97061	Class II	Ongoing	Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Ster	Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.	accessdata.fda.gov

Compare with other makers

Updated July 17, 2025. 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.