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0 & M Halyard, Inc.

USA · Alpharetta

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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

0 & 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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