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INFINIUM MEDICAL, INC.

USA · Largo

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Israel — 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

20listed device types

Class I 7Class II 13Class III 0

plus 22 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States22 registration records, 7 510(k), 0 PMA

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: INFINIUM MEDICAL, INC. · Infinium Medical, Inc.

FDA 510(k) clearances by year

22010 · K103268

22011 · K112329

12014 · K132229

12015 · K142244

12026 · K260438

FDA listed device types

showing 8 of 20

Electrosurgical, Cutting & Coagulation & Accessories 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Measurement, Blood-Pressure, Non-Invasive 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1System, Imaging, Pulsed Doppler, Ultrasonic 1Monitor, Breathing Frequency 1Gas-Machine, Anesthesia 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260438	Vital Signs Monitor (CLEO2)	2026-08-14
US	K142244	CLEO PATIENT MONITOR	2015-02-06
US	K132229	OMNI PATENT MONITORS	2014-02-21
SA	ME0000006263SFDAA00008	ClearVue Video Laryngoscope	—

INFINIUM MEDICAL, 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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