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Philips Healthcare (Cleveland)

USA · Cleveland

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

3listed device types

Class I 0Class II 3Class III 0

plus 8 registration records and 196 510(k), 19 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

4active device licences

Class II 4

5 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 States8 registration records, 196 510(k), 19 PMA, 9 excluded

Brazil1 confirmed, 0 excluded

Canada4 confirmed, 1 excluded

Manufacturer names merged into this page: Philips Medical Systems (Cleveland), Inc. · PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. · PHILIPS MEDICAL SYSTEMS (CLEVELAND),INC.

Same-named companies — This database also contains companies with near-identical names: Philips Medical Systems (Cleveland), Inc., Phillips Medical Systems (Cleveland), Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

121995

151996

91997

131998

111999

32000

52001

12002

52003

62004

22005

12006

42008

42009

32011

12012

42013

12014

22016

52017

FDA listed device types

System, Nuclear Magnetic Resonance Imaging 1System, Planning, Radiation Therapy Treatment 1Accelerator, Linear, Medical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K171850	Philips CT Big Bore	2017-11-09
US	K172406	Ingenuity TF	2017-10-06
US	K162838	Philips iCT CT System	2017-04-07
BR	10216710197	CENTRAL DE PROCESSAMENTO DE IMAGENS MÉDICAS	Class I
CA	15814	SOLUS EPIC CAMERA	Class II
CA	15816	VERTEXPLUS EPIC CAMERA/PEGASYS ULTRA IMAGING SYSTEM	Class II
CA	15822	CARDIO EPIC CAMERA/PEGASYS ULTRA IMAGING SYSTEM	Class II

Philips Healthcare (Cleveland)

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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