Not currently registered with FDA under this name

Terumo Medical Corp.

Elkton, MD, United States. Named as applicant on 1 dental 510(k) clearance between 1987 and 1987. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 11987–1987
Markets registered in: 645 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1980–2026

Registered in 6 markets

Where regulators' registries name Terumo Medical Corp. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Terumo Medical Corp.	1 clearances	1987–1987	Below
Taiwan	TFDA	Manufacturer	TERUMO MEDICAL CORPORATIONTerumo Medical Corp.	17	1988–2013	Pure Global AI
Israel	AMAR	Manufacturer	Terumo Medical Corporation	13	—	Pure Global AI
Brazil	ANVISA	Manufacturer	TERUMO MEDICAL CORPORATION	7	2008–2021	Pure Global AI
Colombia	INVIMA	Manufacturer	TERUMO MEDICAL CORPORATION	6	—	Pure Global AI
Peru	DIGEMID	Manufacturer	TERUMO MEDICAL CORP.	2	2014–2019	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

510(k) clearances

Clearances on which FDA names Terumo Medical Corp. as the applicant.

Decided	510(k)	Device	Device type
10 Mar 1987	K864970	TERUMO DENTAL NEEDLES	DZM Dental Needle

Sources

FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.