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Avanos Medical, Inc.

USA · Alpharetta

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

61listed device types

Class I 22Class II 38Class III 1

plus 133 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

60registered devices

Class I 26Class II 34

85 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

7active device licences

Class II 7

90 including historic records

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

48device registrations

CLASS B 26CLASS C 19CLASS D 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

73active ARTG entries

Class I 19Class III 5IVD Class 2 1IIa 21IIb 14Class Is (sterile) 13

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

21registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 2Class 2b 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States133 registration records, 8 510(k), 0 PMA

Brazil60 confirmed, 0 excluded

Canada7 confirmed, 1 excluded

Manufacturer names merged into this page: Avanos Medical, Inc. · AVANOS MEDICAL, INC.

FDA 510(k) clearances by year

12019 · K191340

22020 · K203066

12022 · K220588

32024 · K241185

12025 · K243572

FDA listed device types

showing 8 of 61

Electrosurgical, Cutting & Coagulation & Accessories 1Endoscopic Injection Needle, Gastroenterology-Urology 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1Endoscopic Access Overtube, Gastroenterology-Urology 1Endoscopic Grasping/Cutting Instrument, Non-Powered 1General Surgery Tray 1Laparoscope, General & Plastic Surgery 1Catheter, Conduction, Anesthetic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243572	Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La	2025-01-31
US	K241185	CORGRIP* SR NG/NI Tube Retention System	2024-10-25
US	K242057	COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)	2024-08-14
BR	10234400051	HASTE PARA HIGIENIZACAO ORAL DENTASWAB	Class I
BR	10234400183	Haste para higienização oral e profilaxia sem dentifrício - DentaSwab	Class I
BR	80102519131	TUNELIZADOR DE FLUÍDO COM BAINHA ON-Q *	Class II
CA	21498	CORFLO - CUBBY GASTROSTOMY FEEDING DEVICE	Class II
CA	36360	GASTROSTOMY TUBES	Class II
CA	77629	MEDIBAG	Class II

Avanos Medical, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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