Home›USA›Siemens Medical Corp.

Siemens Medical Corp.

USA · Iselin

✓ Record-verifiedregistrations found in 4 markets

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

22listed device types

Class I 3Class II 18Class III 1

plus 165 registration records and 943 510(k), 40 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

25registered devices

Class I 1Class II 24

43 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

60active device licences

Class II 28Class III 31Class IV 1

131 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

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 States165 registration records, 943 510(k), 40 PMA, 47 excluded

Brazil25 confirmed, 46 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada60 confirmed, 10 excluded

Manufacturer names merged into this page: SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. · SIEMENS MEDICAL SOLUTIONS USA, INC. · Siemens Medical Solutions USA, Inc. · SIEMENS MEDICAL SOLUTIONS USA, INC. ONCOLOGY CARE SYSTEMS · SIEMENS MEDICAL SOLUTIONS USA, INC. MOLECULAR IMAGING · SIEMENS AG MEDICAL SOLUTIONS

FDA 510(k) clearances by year

352007

232008

192009

152010

202011

242012

312013

332014

262015

222016

302017

282018

262019

352020

252021

332022

292023

242024

172025

92026

FDA listed device types

showing 8 of 22

Device, Beam Limiting, X-Ray, Diagnostic 1Image-Intensified Fluoroscopic X-Ray System, Mobile 1System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Tomography, Computed, Emission 1Transducer, Ultrasonic, Diagnostic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253786	syngo.CT Coronary Cockpit	2026-06-25
US	K253678	MAMMOMAT B.brilliant (11372950)	2026-06-18
US	K260844	ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System	2026-06-16
BR	10345160873	PROLACTIN IMMULITE 2000	Class II
BR	10345160777	RAPID TSH IMMULITE 2000	Class II
BR	10345160880	ACTH CONTROL MODULE IMMULITE	Class II
CA	15152	SIMVIEW NT	Class III
CA	4950	MULTISPECT 3	Class II
CA	4956	ICON WORKSTATION	Class II

Siemens Medical Corp.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies