Manufacturer registered with FDA

Avanos Medical, Inc.

Alpharetta, GA, United States. Lists 2 dental device types with FDA across 2 registered establishments.

FDA owner/operator2022573ManufacturerSpecification developer
Device types listed
2
Brands and models
5
510(k) clearances
0as applicant
Markets registered in
15971 registrations outside the US
Establishments
2Mexico, United States

Registered in 15 markets

Where regulators' registries name Avanos Medical, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 2 device types listedCanada: 324 registrationsColombia: 170 registrationsCosta Rica: 108 registrationsBrazil: 70 registrationsAustralia: 69 registrationsSaudi Arabia: 68 registrationsUnited Kingdom: 47 registrationsSerbia: 38 registrationsTaiwan: 23 registrationsIsrael: 21 registrationsSouth Korea: 14 registrationsPeru: 11 registrationsEuropean Union: 6 registrationsHong Kong: 2 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerAvanos Medical, Inc.2 device types—Below
CanadaHealth CanadaRegistration holderAVANOS MEDICAL, INC.3241998–2026Pure Global AI
ColombiaINVIMARegistration holderAVANOS MEDICAL, INC.AVANOS MEDICAL INC · AVENT S. DE R.L. DE C.V. · +2170—Pure Global AI
Costa RicaMinisterio de SaludManufacturerAVENT S. DE R.L. DE C.V.AVENT S. de R.L. de C.V. · AVENT S. DE RL DE C.V. · +2108—Pure Global AI
BrazilANVISAManufacturerAVANOS MEDICAL, INC.AVENT S. DE R.L. DE C.V.702002–2026Pure Global AI
AustraliaTGAManufacturerAvanos Medical Inc692014–2026Pure Global AI
Saudi ArabiaSFDAManufacturerAvanos Medical, Inc.68—Pure Global AI
United KingdomMHRAManufacturerAvanos Medical, Inc.47—Pure Global AI
SerbiaALIMSManufacturerAvanos Medical Inc.382022–2026Pure Global AI
TaiwanTFDAManufacturerAvanos Medical, Inc.Avent S. de R.L. de C.V. · AVENT S. DE R.L. DE C.V. · +1232005–2026Pure Global AI
IsraelAMARManufacturerAvanos Medical Inc.Avanos Medical Inc · Avanos Medical, Inc. · +221—Pure Global AI
South KoreaMFDSManufacturerAvent S. de R.L. de C.V.Avent S.de R.L.de C.V. · AVENT S. de R.L de C.V. · +1142003–2022Pure Global AI
PeruDIGEMIDManufacturerAVANOS MEDICAL INC.AVANOS MEDICAL Inc.112022–2026Pure Global AI
European UnionEUDAMEDRegistration holderAvanos Medical, Inc.6—Pure Global AI
Hong KongMDDManufacturerAvanos Medical Inc.Avanos Medical, Inc.22026–2026Pure 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

Devices listed with FDA

What Avanos Medical, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Manual ToothbrushEFW · Class 1ToothbrushesMaker
DENTASWABKimVent Oral CareSOFSWABToothbrush
2014
Patient Personal Hygiene KitNSB · Class 1—Maker
cleaning, non-sterile
2023

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Registered establishments

EstablishmentLocationWhat it does
Avanos Medical, Inc.FDA reg. 3011270181Alpharetta, GA, United StatesComplaint file establishment, Specification developer
AVENT S. de R.L. de C.V.FDA reg. 9611594NOGALES Sonora, MexicoManufacturer

Other names on FDA records

Avent S. de R.L. de C.V.

Sources

FDA establishment registration & device listing (search FDA, owner/operator 2022573). 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.