Rapid-Medical , Ltd. FDA Approvals

0 new drug approvals and 10 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Hyperdrive 35 Guidewire510(k)Sep 18, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 18, 2026
Tigertriever 13 Ultra Revascularization Device510(k)Aug 28, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 28, 2026
Drivewire 35 Guidewire510(k)Jul 17, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 17, 2026
Tigertriever 25 Revascularization Device510(k)Mar 12, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 12, 2026
Tigertriever 17 Ultra Revascularization Device510(k)Oct 6, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 6, 2025
Drivewire 24 Guidewire510(k)Jul 11, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 11, 2024
BraidE Embolization Assist Device510(k)Feb 21, 2024Cardiovascular	Cardiovascular	510(k)Unknown (Direct)	Feb 21, 2024
Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device510(k)Apr 17, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Apr 17, 2023
Tigertriever 13 Revascularization Device510(k)Jul 25, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 25, 2022
Tigertriever and Tigertriever 17 Revascularization Devce510(k)Mar 23, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 23, 2021