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S.I.M.E.O.N. MEDICAL USA, LLC

USA · Greenville

✓ 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

181listed device types

Class I 92Class II 84Class III 3unclassified 2

plus 376 registration records and 901 510(k), 21 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

22registered devices

Class II 22

29 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

64active device licences

Class II 37Class III 26Class IV 1

132 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 States376 registration records, 901 510(k), 21 PMA, 565 excluded

Brazil22 confirmed, 39 excluded

Saudi Arabia0 confirmed, 12 excluded

Canada64 confirmed, 61 excluded

Manufacturer names merged into this page: CANARY MEDICAL USA LLC · INVENT MEDICAL USA, LLC · HG MEDICAL USA, LLC · METIER MEDICAL (USA) LLC · SIEMENS MEDICAL SOLUTIONS USA, INC. ONCOLOGY CARE SYSTEMS · SIEMENS MEDICAL SOLUTIONS USA, INC.

FDA 510(k) clearances by year

242007

152008

142009

112010

182011

172012

292013

302014

252015

212016

312017

312018

272019

362020

272021

352022

302023

262024

182025

112026

FDA listed device types

showing 8 of 181

Electrosurgical, Cutting & Coagulation & Accessories 1Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Cerclage, Fixation 1Light, Surgical, Accessories 1Washer, Bolt Nut 1Tubes, Vials, Systems, Serum Separators, Blood Collection 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260835	ARCHIMEDES Biodegradable Stent (Medium)	2026-07-27
US	K253786	syngo.CT Coronary Cockpit	2026-06-25
US	K253678	MAMMOMAT B.brilliant (11372950)	2026-06-18
BR	10345162479	syngo MBF	Class II
BR	10345162490	syngo.via MI Workflows	Class II
BR	10345162501	Scenium	Class II
CA	15152	SIMVIEW NT	Class III
CA	4950	MULTISPECT 3	Class II
CA	4956	ICON WORKSTATION	Class II

S.I.M.E.O.N. MEDICAL USA, LLC

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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