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Ohmeda Medical, A Division of Datex-Ohmeda, Inc.

USA · Laurel

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Israel — 5 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

20listed device types

Class I 5Class II 14Class III 1

plus 102 registration records and 229 510(k), 1 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

7 including historic records

SASaudi ArabiaSFDA

7registered imported devices

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

CACanadaMDALL

28active device licences

Class II 6Class III 22

73 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States102 registration records, 229 510(k), 1 PMA, 2 excluded

Brazil1 confirmed, 0 excluded

Saudi Arabia7 confirmed, 0 excluded

Canada28 confirmed, 0 excluded

Manufacturer names merged into this page: Datex-Ohmeda, Inc. · DATEX-OHMEDA, INC. · OHMEDA MEDICAL, A DIVISION OF DATEX OHMEDA INC. · DATEX-OHMEDA · DATEX OHMEDA INC · DATEX-OHMEDA INC.

Same-named companies — This database also contains companies with near-identical names: Datex-Ohmeda, Inc., Datex-Ohmeda Inc., A Division of Instrumentarium C, Datex-Ohmeda, Inc., A General Electric Company, Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

122003

112004

102005

32006

62007

32008

22009

52010

32011

22012

42013

42015

22016

22017

12018

12021

22022

22023

12025

22026

FDA listed device types

showing 8 of 20

Uterine Electromyographic Monitor 1Apparatus, Gas-Scavenging 1Cable, Electrode 1Vaporizer, Anesthesia, Non-Heated 1Electrode, Electrocardiograph 1Incubator, Neonatal 1Gas-Machine, Anesthesia 1Ventilator, Emergency, Manual (Resuscitator) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254036	Novii+ Wireless Patch System	2026-08-10
US	K260326	Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)	2026-07-28
US	K251663	Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)	2025-10-22
BR	80071260263	SISTEMA DE FOTOTERAPIA LED	Class II
SA	ME0000003425SFDAA00018	Reusable Infant Temperature Probe	—
SA	ME0000003425SFDAA00017	IV Pole	—
CA	61140	O2 FLOWMETER	Class II
CA	70622	IVENT201 VENTILATOR	Class III
CA	70747	THE IVENT PATIENT BREATHING CIRCUITS	Class II

Ohmeda Medical, A Division of Datex-Ohmeda, 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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