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Varian Medical Systems, Inc.

USA · Palo Alto

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

19listed device types

Class I 2Class II 17Class III 0

plus 191 registration records and 212 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

48 including historic records

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

23active device licences

Class II 9Class III 14

86 including historic records

TWTaiwanTFDA

22valid device licences

Class I 2Class II 18Class III 2

SGSingaporeHSA SMDR

21device registrations

CLASS B 2CLASS C 18CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

38active ARTG entries

Class I 5Class III 1IIa 16IIb 16

HKHong KongMDACS

2valid listings

Class III 2

ILIsraelAMAR

18registrations

RURussiaRoszdravnadzor

18active registrations

Class 1 1Class 2a 1Class 2b 15Class 3 1

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 States191 registration records, 212 510(k), 0 PMA, 4 excluded

Brazil2 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada23 confirmed, 0 excluded

Manufacturer names merged into this page: Varian Medical Systems, Inc · Varian Medical Systems China Co., Ltd. · Varian Medical Systems Haan GmbH · Varian Medical Systems Hungary Kft. · VARIAN MEDICAL SYSTEMS, INC. · VARIAN MEDICAL SYSTEMS INC.

FDA 510(k) clearances by year

112007

32008

72009

62010

42011

82012

82013

152014

112015

72016

102017

122018

52019

52020

62021

72022

122023

152024

102025

82026

FDA listed device types

showing 8 of 19

System, Applicator, Radionuclide, Remote-Controlled 1Agents, Embolic, For Treatment Of Uterine Fibroids 1System, Image Processing, Radiological 1System, Planning, Radiation Therapy Treatment 1Instrument, Biopsy 1System, Simulation, Radiation Therapy 1Unit, Cryosurgical, Accessories 1Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261856	Halcyon, Ethos Radiotherapy System (5.0)	2026-08-03
US	K261306	AI Contouring (VA10A)	2026-07-10
US	K260750	Virtual Cone (1.0)	2026-07-08
BR	10405410028	VELOCITY AI	Class II
BR	10405419001	Kit de Cateteres de Aquecimento Uretral Varian	Class II
SA	ME0000010234SFDAA00074	Sterilization Boxes	—
CA	60664	ARGUS QA PRODUCTS	Class II
CA	62860	BRACHYVISION 6.0	Class III
CA	68476	VARIAN MEDICAL SYSTEMS BRACHYTHERAPY NEEDLES	Class II