FDA.reportPublic FDA data

PHYSIO-CONTROL, INC.

Matched from indexed company URL: Physio-Control, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30158763015876PHYSIO-CONTROL, INC.1Y2026-01-0111811 WILLOWS RD., N.E. Redmond WA US 98052
30100303553010030355PHYSIO-CONTROL MAASTRICHT, INC.1N2026-01-01Gaetano Martinolaan 50 Maastricht Limburg NL 6229 GS

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00883873030608LIFEPAK 15 AC Power Adapter - AC Power Adapter+1(800)442-1142rs.seacustomersupport@stryker.com
00883873031902LIFEPAK 35 Monitor/Defibrillator - ENGLISH US,CONFIG B SPO2,MEDTRONIC CO2,SUNTECH NIBP,IP AND TEMP,GLASGOW+1(800)442-1142rs.seacustomersupport@stryker.com
00883873031933LIFEPAK 35 Monitor/Defibrillator - ENGLISH US,CONFIG B SPO2_CO,MEDTRONIC CO2,SUNTECH NIBP,NO IP OR TEMP+1(800)442-1142rs.seacustomersupport@stryker.com
00883873031957LIFEPAK 35 Monitor/Defibrillator - ENGLISH US,CONFIG B SPO2,MEDTRONIC CO2,SUNTECH NIBP,NO IP OR TEMP+1(800)442-1142rs.seacustomersupport@stryker.com
00883873031971LIFEPAK 35 Monitor/Defibrillator - ENGLISH US,CONFIG B SPO2,MEDTRONIC CO2,SUNTECH NIBP,IP AND TEMP,ENABLED+1(800)442-1142rs.seacustomersupport@stryker.com
00883873031995LIFEPAK 35 Monitor/Defibrillator - ENGLISH US,CONFIG B SPO2,MEDTRONIC CO2,SUNTECH NIBP,NO IP OR TEMP+1(800)442-1142rs.seacustomersupport@stryker.com
00883873032015LIFEPAK 35 Monitor/Defibrillator - ENGLISH US,CONFIG B SPO2,MEDTRONIC CO2,SUNTECH NIBP,IP AND TEMP,GLASGOW+1(800)442-1142rs.seacustomersupport@stryker.com
00883873032145LIFEPAK 35 Monitor/Defibrillator - 35P,ENGLISH US,CONFIG B SPO2,MEDTRONIC CO2,SUNTECH NIBP,IP AND TEMP+1(800)442-1142rs.seacustomersupport@stryker.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2128561539263216P190007Cardinal Health Multifunctional Defibrillation ElectrodeMKJ2020-08-07
2209761849399444P170018LIFEPAK® CR2 DefibrillatorMKJ2018-12-21
2128561871864779P170018LIFEPAK® CR2 DefibrillatorMKJ2018-12-21
2209761059326393P160026LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DEMKJ2018-07-02
2128561203580768P160026LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DEMKJ2018-07-02
2209761203760934P160012LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery ChargerMKJ2017-12-21
2128561952510700P160012LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery ChargerMKJ2017-12-21
2128561876354737K912599QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELECDRO1991-09-11
2128561956641361K253099LIFEPAK 15 AC Power Adapter (41577-000333)MPD2025-10-14
2128561864545246K240377LIFEPAK® ECG CablesDSA2024-05-07
2128561151710840K240162LIFEPAK® 35 AC Power Adapter (41335-000001)MPD2024-04-19
2128562003278646K240156LIFEPAK® 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)DSA2024-04-30
2128561564285933K182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsLDD2019-06-03
2209761209220210K173553LUCAS 3 Chest Compression SystemDRM2018-02-08
2128561693779687K173553LUCAS 3 Chest Compression SystemDRM2018-02-08
2128561041100631K161768LUCAS 3 Chest Compression SystemDRM2016-11-09
2209761414256578K161768LUCAS 3 Chest Compression SystemDRM2016-11-09
2128561732235213K142430LIFEPAK 15 monitor/defibrillatorMKJ2014-12-19
2128561541624746K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORMKJ2013-08-21
2128561017040332K123597TRUECPR COACHING DEVICELIX2013-04-17
2128561530197498K122600LIFEPAK 1000 DEFIBRILLATORMKJ2012-10-11
2128561384247554K103567LIFEPAK 15 MONITOR/DEFIBRILLATORMKJ2011-03-22
2128561275489616K102972LIFEPAK 12MKJ2010-12-22
2209761679063266K102972LIFEPAK 12MKJ2010-12-22
2128561823593467K090422LUCAS 2DRM2009-06-17
2209761969702614K090422LUCAS 2DRM2009-06-17
2128561319339521K062401MODIFICATION TO LUCASDRM2006-09-28
2128561153879390K053403LUCASDRM2006-02-01
2128561295472081K052057LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATORMKJ2006-02-17
2209761569645854K052057LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATORMKJ2006-02-17
2128561554797301K022732INFANT/CHILD REDUCED ENERGY ELECTRODESMKJ2002-12-13
2128561907391061K011144LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATORMKJ2001-12-03
2128561053827296
2128561178024339

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MKJ242018-12-21
DRM132018-02-08
MPD22025-10-14
DSA22024-05-07
LDD22019-06-03
MKJ 12020-08-07
LIX12013-04-17
DRO11991-09-11

PMA#

LIFEPAK® CR2 Defibrillator

2023-01-10

Physio-Control, Inc11811 Willows Road Neredmond, WA 98052 PMA NumberP170018 Supplement NumberS015 Date Received10/13/2022 Decision Date01/10/2023 Product Code MKJ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change D...

LIFEPAK Automated External Defibrillators (AEDs)

2023-01-04

Physio-Control. Inc.11811 Willows Road Neredmond, WA 98052 PMA NumberP160026 Supplement NumberS037 Date Received12/22/2022 Decision Date01/04/2023 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...

LIFEPAK® 15 Monitor/Defibrillator

2022-12-12

Physio-Control. Inc.11811 Willows Road Neredmond, WA 98052 PMA NumberP160026 Supplement NumberS036 Date Received12/06/2022 Decision Date12/12/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...

LIFEPAK Automated External Defibrillators (AEDs)

2022-11-10

Physio-Control. Inc.11811 Willows Road Neredmond, WA 98052 PMA NumberP160026 Supplement NumberS035 Date Received10/31/2022 Decision Date11/10/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...

LIFEPAK Automated External Defibrillators (AEDs)

2022-10-27

Physio-Control. Inc.11811 Willows Road Neredmond, WA 98052 PMA NumberP160026 Supplement NumberS034 Date Received10/14/2022 Decision Date10/27/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...

LIFEPAK® CR2 Defibrillator

2022-09-27

Physio-Control, Inc11811 Willows Road Neredmond, WA 98052 PMA NumberP170018 Supplement NumberS014 Date Received07/27/2022 Decision Date09/27/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Process ...

QUIK-COMBO® Therapy Cable

2022-08-16

Physio-Control. Inc.11811 Willows Road Neredmond, WA 98052 PMA NumberP160026 Supplement NumberS033 Date Received07/22/2022 Decision Date08/16/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Cha...

LIFEPAK Automated External Defibrillator (AED)

2022-07-28

Physio-Control. Inc.11811 Willows Road Neredmond, WA 98052 PMA NumberP160026 Supplement NumberS031 Date Received05/13/2022 Decision Date07/28/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change ...

QUIK-PAK Electrodes

2022-07-20

Physio-Control. Inc.11811 Willows Rd. Neredmond, WA 98052 PMA NumberP160012 Supplement NumberS006 Date Received05/16/2022 Decision Date07/20/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling...

45 records. Showing 1-40. Next

PMN#

89 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next