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Philips Medical Systems North America, Inc.

USA · Bothell

✓ 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

84listed device types

Class I 13Class II 69Class III 2

plus 265 registration records and 334 510(k), 63 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 1Class II 3

53 including historic records

SASaudi ArabiaSFDA

141registered imported devices

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

CACanadaMDALL

134active device licences

Class II 98Class III 33Class IV 3

380 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 States265 registration records, 334 510(k), 63 PMA, 94 excluded

Brazil4 confirmed, 18 excluded

Saudi Arabia141 confirmed, 13 excluded

Canada134 confirmed, 25 excluded

Manufacturer names merged into this page: Philips Medical Systems Ltda · Philips North America LLC · Philips DS North America LLC · PHILIPS MEDICAL SYSTEMS · RESPIRONICS INC. ALSO TRADING AS PHILIPS RS NORTH AMERICA LLC · PHILIPS MEDICAL SYSTEMS.

FDA 510(k) clearances by year

172004

102005

122006

92007

82008

62009

72010

82011

42012

72013

42014

42015

42016

32017

12018

12019

22020

42021

22025

22026

FDA listed device types

showing 8 of 84

System, Network And Communication, Physiological Monitors 1Detector And Alarm, Arrhythmia 1Electrocardiograph, Ambulatory (Without Analysis) 1Uterine Electromyographic Monitor 1Index-Generating Electroencephalograph Software 1Amplifier And Signal Conditioner, Transducer Signal 1Radiological Image Processing Software For Ablation Therapy Planning And Evaluation 1Antimicrobial Blood Pressure Cuff 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253670	SmartCT (R3.0 (L10))	2026-07-10
US	K254186	Azurion R3.1	2026-01-16
US	K251827	Azurion R3.1	2025-10-24
BR	10216710382	IntelliSpace Precision Medicine Pathology Genomics Workspace	Class II
BR	10216710197	CENTRAL DE PROCESSAMENTO DE IMAGENS MÉDICAS	Class I
BR	10216710396	IntelliSpace ECG	Class II
SA	ME0000009235SFDAA00001	Disposable Abdominal Belt	—
SA	ME0000009235SFDAA00002	Efficia 50mm Chemical Thermal Paper, No Gridlines	—
CA	1108	EASI VIEW	Class II
CA	1386	WALLABY 3 PHOTOTHERAPY SYSTEM	Class III
CA	6903	PULSE OXIMETER	Class III

Philips Medical Systems North America, 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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