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Nellcor Puritan Bennett, Inc.

USA · Pleasanton

✓ Record-verifiedregistrations found in 4 markets

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

51510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 51 510(k), 7 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class II 5

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

27active device licences

Class II 6Class III 21

34 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 1IIb 1

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 States0 registration records, 51 510(k), 7 PMA, 1 excluded

Brazil5 confirmed, 0 excluded

Canada27 confirmed, 0 excluded

Manufacturer names merged into this page: NELLCOR PURITAN BENNETT INC. (A SUBSIDIARY OF MALLINCKORDT, INC.) · NELLCOR PURITAN BENNETT IRELAND · NELLCOR PURITAN BENNETT INC. · NELLCOR PURITAN BENNETT (MELVILLE) LTD. · NELLCOR PURITAN BENNETT MEXICO, SA DE CV · NELLCOR PURITAN BENNET, INC.

Same-named companies — This database also contains companies with near-identical names: Covidien, Formerly Nellcor Puritan Bennett, Inc., NELLCOR PURITAN BENNETT IRELAND, NELLCOR PURITAN BENNETT MEXICO, SA DE CV. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K123581	NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN	2013-05-09
US	K123002	VITAL SYNC SYSTEM	2013-02-27
US	K092847	840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION	2010-03-11
BR	10349000226	AGULHA DE ACESSO E INSUFLACAO VERSASTEP	Class II
BR	10349000350	SATIN-SLIP - GUIA LUBRIFICADO PARA INTUBACAO	Class II
BR	10349000413	Tubo Endotraqueal TaperGuard com Lumen EVAC	Class II
CA	6997	SANDMAN SLEEP DIAGNOSTIC SYSTEM AND SANDMAN NT (SOFTWARE)	Class II
CA	7959	BREATH STAR 340 VENTILATOR SYSTEM	Class III
CA	12781	ASSURANCE 2000 HEAT/RESPIRATION MONITOR (PREVIOUSLY NAMED 2000W)	Class III

Nellcor Puritan Bennett, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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