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CareFusion 303, INC.

USA · San Diego

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Saudi Arabia, Canada, Singapore, Australia, Israel — 6 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

6listed device types

Class I 1Class II 5Class III 0

plus 19 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

6active device licences

Class II 6

12 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

IIb 6

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States19 registration records, 7 510(k), 0 PMA, 1 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: CareFusion 303, INC · CareFusion 303, INC. · CAREFUSION 303, INC. · CareFusion 303, Inc.

FDA 510(k) clearances by year

12011 · K110809

12012 · K110535

12014 · K133532

22017 · K171957

12023 · K211218

12025 · K243855

FDA listed device types

Pump, Infusion, Pca 1Pump, Infusion 1Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 1Infusion Safety Management Software 1Oximeter 1Cabinet, Table And Tray, Anesthesia 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243855	BD Alaris Infusion System with Guardrails Suite MX	2025-04-25
US	K211218	BD Alaris System with Guardrails Suite MX v12.1.2	2023-07-21
US	K171957	MaxZero Extension Sets with Needless Connector	2017-07-19
SA	ME0000001872SFDAA00013	Infusion Adapter	—
CA	4989	IVAC VITAL CHECK MEASUREMENT SYSTEM	Class II
CA	5818	IVAC COMPUTER INTERFACE MODULE	Class II
CA	60681	SIGNATURE GOLD EDITION GUARDRAILS SAFETY SOFTWARE	Class II

CareFusion 303, 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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