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PHYSIO-CONTROL, INC.

USA · Redmond

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

14listed device types

Class I 2Class II 11Class III 1

plus 23 registration records and 104 510(k), 101 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

5registered imported devices

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

CACanadaMDALL

12active device licences

Class II 4Class III 5Class IV 3

52 including historic records

TWTaiwanTFDA

6valid device licences

Class II 2Class III 4

SGSingaporeHSA SMDR

6device registrations

CLASS C 5CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

33active ARTG entries

Class I 21Class III 4IIa 1IIb 7

HKHong KongMDACS

3valid listings

Class III 2Class IV 1

ILIsraelAMAR

14registrations

RURussiaRoszdravnadzor

5active registrations

Class 2b 5

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 States23 registration records, 104 510(k), 101 PMA, 11 excluded

Saudi Arabia5 confirmed, 1 excluded

Canada12 confirmed, 5 excluded

Manufacturer names merged into this page: PHYSIO-CONTROL, INC. · PHYSIO-CONTROL MAASTRICHT, INC. · Physio-Control, Inc.

FDA 510(k) clearances by year

31994

31995

21996

11997

11998

31999

42001

22002

12003

12004

12008

12009

32010

12011

12012

22013

12014

12019

32024

12025

FDA listed device types

showing 8 of 14

System, Measurement, Blood-Pressure, Non-Invasive 1Cable, Transducer And Electrode, Patient, (Including Connector) 1Dc-Defibrillator, Low-Energy, (Including Paddles) 1Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 1Computer, Blood-Pressure 1Oximeter 1Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator 1Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253099	LIFEPAK 15 AC Power Adapter (41577-000333)	2025-10-14
US	K240377	LIFEPAK® ECG Cables	2024-05-07
US	K240156	LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024)	2024-04-30
SA	ME0000001047SFDAA00037	15 Li-ion Rechargeable Battery	—
SA	ME0000001047SFDAA00041	QUIK-COMBO® RTS Pediatric Pacing/Defibrillation/ECG Electrode Radiotra	—
CA	27353	FAST-PATCH DEFIBRILLATION ELECTRODES	Class II
CA	36524	QUIK-COMBO CONNECTORS	Class II
CA	61546	QUIK-COMBO REDI-PAK PACING/DEFIBRILLATION/ECG ELECTRODE	Class II