Not currently registered with FDA under this name

Nellcor Puritan Bennett, Inc.

Eden Prairie, MN, United States. Named as applicant on 2 dental 510(k) clearances between 1996 and 1997. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
21996–1997
Markets registered in
690 registrations outside the US
Establishments
0—
1996: 11997: 11990200020102020

510(k) clearances per year, 1990–2026

Registered in 6 markets

Where regulators' registries name Nellcor Puritan Bennett, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 2 clearancesCanada: 44 registrationsSouth Korea: 41 registrationsTaiwan: 3 registrationsBrazil: 1 registrationsHong Kong: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantNellcor Puritan Bennett, Inc.2 clearances1996–1997Below
CanadaHealth CanadaRegistration holderNELLCOR PURITAN BENNETT INC.441999–1999Pure Global AI
South KoreaMFDSManufacturerNellcor Puritan Bennett Inc.Nellcor Puritan Bennett Incorporated. · Nellcor Puritan Bennett Incorporated · +2411998–2004Pure Global AI
TaiwanTFDAManufacturerNELLCOR PURITAN BENNETT INC.31995–1997Pure Global AI
BrazilANVISAManufacturerNELLCOR PURITAN BENNETT INC12014–2014Pure Global AI
Hong KongMDDManufacturerNellcor Puritan Bennett Inc.12009–2009Pure 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 Nellcor Puritan Bennett, Inc. as the applicant.

Decided510(k)DeviceDevice type
24 Jan 1997K964516TAPLRK Anti-Snoring Device
10 Sep 1996K962516TAP ANTI-SNORING DEVICELRK Anti-Snoring 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.