Data / Medical devices / Israel / Rapid-Medical Ltd

Rapid-Medical Ltd: FDA-registered device maker in yokneam Northern, Israel, 12 510(k) clearances

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

Rapid-Medical Ltd is registered with the FDA (registration 3009957947) in yokneam Northern, Israel. It lists 5 device types. The FDA files 12 510(k) clearances under its listings, the newest dated September 18, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009957947
Address: Carmel Building POB337, yokneam Northern, Israel, 2069205
Owner or operator: Rapid-Medical (10060398)
Roles: Complaint file establishment, Manufacturer
First device listed: May 8, 2019
Registered through: 2026
Brand names listed: BraidE Embolization Assist Device, Comaneci, Comaneci 17, Comaneci Petit, Drivewire 14 LR (previously Columbus 14 LR), Drivewire 14 SR (previously Columbus 14 SR), Drivewire 24 Guidewire, Drivewire 35 Guidewire and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Thrombus Retriever	NRY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Guide, Wire, Catheter, Neurovasculature	MOF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Temporary Coil Embolization Assist Device	PUU	2	Manufacturer	accessdata.fda.gov
Temporary Embolization Assist Device, Peripheral	QZU	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Complaint file establishment, 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
September 18, 2026	K253146	Hyperdrive 35 Guidewire	DQX	Substantially Equivalent	Rapid-Medical , Ltd.	accessdata.fda.gov
August 28, 2026	K260617	Tigertriever 13 Ultra Revascularization Device	NRY	Substantially Equivalent	Rapid Medical Ltd.	accessdata.fda.gov
July 17, 2026	K254006	Drivewire 35 Guidewire	MOF	Substantially Equivalent	Rapid Medical Ltd.	accessdata.fda.gov
March 12, 2026	K253062	Tigertriever 25 Revascularization Device	NRY	Substantially Equivalent	Rapid Medical Ltd.	accessdata.fda.gov
October 6, 2025	K251603	Tigertriever 17 Ultra Revascularization Device	NRY	Substantially Equivalent	Rapid Medical Ltd.	accessdata.fda.gov
July 11, 2024	K233791	Drivewire 24 Guidewire	MOF	Substantially Equivalent	Rapid-Medical , Ltd.	accessdata.fda.gov
February 21, 2024	DEN230064	BraidE Embolization Assist Device	QZU	Unknown	Rapid Medical Ltd.	accessdata.fda.gov
April 17, 2023	K230429	Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device	NRY	Substantially Equivalent	Rapid Medical Ltd.	accessdata.fda.gov
July 25, 2022	K220808	Tigertriever 13 Revascularization Device	NRY	Substantially Equivalent	Rapid Medical Ltd.	accessdata.fda.gov
March 23, 2021	K203592	Tigertriever and Tigertriever 17 Revascularization Devce	NRY	Substantially Equivalent	Rapid Medical Ltd.	accessdata.fda.gov
December 14, 2020	K200374	Columbus Guidewire	MOF	Substantially Equivalent	Rapid-Medical , Ltd.	accessdata.fda.gov
April 24, 2019	DEN170064	Comaneci, Comaneci Petit, Comaneci 17	PUU	Unknown	Rapid-Medical , Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 18, 2026. 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.