HomeUSAMedtronic Physio-Control Corp.

Medtronic Physio-Control Corp.

USA · Redmond
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, 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
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
0valid device licences
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 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.
Same-named companies — This database also contains companies with near-identical names: PHYSIO-CONTROL, INC., Stryker Physio-Control. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Redmond

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

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)

MarketIdentifierNameClass / date
USK253099LIFEPAK 15 AC Power Adapter (41577-000333)2025-10-14
USK240377LIFEPAK® ECG Cables2024-05-07
USK240156LIFEPAK® 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
SAME0000001047SFDAA0003715 Li-ion Rechargeable Battery
SAME0000001047SFDAA00041QUIK-COMBO® RTS Pediatric Pacing/Defibrillation/ECG Electrode Radiotra
CA27353FAST-PATCH DEFIBRILLATION ELECTRODESClass II
CA36524QUIK-COMBO CONNECTORSClass II
CA61546QUIK-COMBO REDI-PAK PACING/DEFIBRILLATION/ECG ELECTRODEClass II

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