Not currently registered with FDA under this name

Ela Medical, Inc.

Minnetonka, MN, United States. Named as applicant on 1 dental 510(k) clearance between 1995 and 1995. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 11995–1995
Markets registered in: 24 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1990–2026

Registered in 2 markets

Where regulators' registries name Ela Medical, Inc. 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	Ela Medical, Inc.	1 clearances	1995–1995	Below
South Korea	MFDS	Manufacturer	ELA Medical	4	2006–2006	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 Ela Medical, Inc. as the applicant.

Decided	510(k)	Device	Device type
15 Aug 1995	K952363	OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)	ELA Calculus Removal Hand Instrument

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.