Not currently registered with FDA under this name

Infimed, Inc.

Liverpool, NY, United States. Named as applicant on 2 dental 510(k) clearances between 1997 and 2000. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 21997–2000
Markets registered in: 44 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1990–2026

Registered in 4 markets

Where regulators' registries name Infimed, 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	Infimed, Inc.	2 clearances	1997–2000	Below
South Korea	MFDS	Manufacturer	InfiMed, Inc.Infimed Inc.	2	2001–2002	Pure Global AI
Australia	TGA	Manufacturer	Infimed Inc	1	2007–2007	Pure Global AI
Taiwan	TFDA	Manufacturer	INFIMED, INC.	1	2008–2008	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 Infimed, Inc. as the applicant.

Decided	510(k)	Device	Device type
31 Mar 2000	K992392	RTLX	MUH Digital Extraoral Source X-Ray System
11 Sep 1997	K962422	INFIMED DENTAL SYSTEM	EHD Extraoral with Timer X-Ray Unit

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.