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O & M HALYARD, INC.

USA · Alpharetta

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia, Israel, Russia — 7 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

127listed device types

Class I 86Class II 40Class III 0unclassified 1

plus 296 registration records and 27 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

120registered devices

Class I 119Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

5registered imported devices

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

CACanadaMDALL

3active device licences

Class II 3

16 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

21active ARTG entries

Class I 15IIa 1Class Is (sterile) 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

3active registrations

Class 1 3

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 States296 registration records, 27 510(k), 0 PMA, 8 excluded

Brazil120 confirmed, 1 excluded

Saudi Arabia5 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: O&M Halyard, Inc. · O & M HALYARD, INC. · O&M HALYARD, INC.

FDA 510(k) clearances by year

42019

32020

32021

52022

52024

32025

42026

FDA listed device types

showing 8 of 127

Electrosurgical, Cutting & Coagulation & Accessories 1Electrode, Electrocardiograph 1Nebulizer (Direct Patient Interface) 1Drape, Surgical, Exempt 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1Bed, Ac-Powered Adjustable Hospital 1Mask, Surgical 1Needle, Hypodermic, Single Lumen 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K262014	PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves	2026-07-21
US	K261897	HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology	2026-07-02
US	K253454	HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap	2026-05-18
BR	81832580097	Máscara de Procedimento Descartável Halyard Nível 2	Class I
BR	81832580098	Máscara Cirúrgica Descartável Halyard Nível 3	Class I
BR	81832580099	Máscara de Procedimento Descartável Nível 3 Fog-Free Halyard	Class I
SA	ME0000004605SFDAA00036	STERLING* NITRILE POWDER-FREE EXAM GLOVES	—
SA	ME0000004605SFDAA00037	BASICS* Blue Powder-Free Nitrile Exam Gloves	—
CA	15871	PMP CONTINUOUS EPIDURAL TRAYS	Class II
CA	16012	PMP ADAPTORS	Class II
CA	95271	EPIDURAL MINI KIT	Class II

O & M HALYARD, 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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