Not currently registered with FDA under this name

Resmed Sas

San Diego, CA, United States. Named as applicant on 1 dental 510(k) clearance between 2011 and 2011. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 12011–2011
Markets registered in: 717 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2007–2026

Registered in 7 markets

Where regulators' registries name Resmed Sas 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	Resmed Sas	1 clearances	2011–2011	Below
Colombia	INVIMA	Manufacturer	RESMED CORP	8	—	Pure Global AI
Taiwan	TFDA	Manufacturer	RESMED CORPORATIONResMed Corp	3	2013–2025	Pure Global AI
Brazil	ANVISA	Manufacturer	RESMED CORP.	2	2022–2025	Pure Global AI
Israel	AMAR	Manufacturer	ResMed Corp.	2	—	Pure Global AI
Peru	DIGEMID	Manufacturer	RESMED CORP	1	2017–2017	Pure Global AI
South Korea	MFDS	Manufacturer	Res Med Ltd	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 Resmed Sas as the applicant.

Decided	510(k)	Device	Device type
1 Dec 2011	K113201	NARVAL CC	LQZ Jaw Repositioning Device

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.