Physio Control Inc

FDA Filings

This page includes the latest FDA filings for Physio Control Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3015876
FEI Number3015876
NamePHYSIO-CONTROL, INC.
Owner & OperatorSTRYKER CORP.
Contact Address1901 Romence Pkwy
Portage MI 49002 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address11811 WILLOWS RD., N.E.
Redmond, WA 98052 US
Establishment Type
  • Manufacture Device in the United States for Export Only
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
PHYSIO-CONTROL, INC.
 LIFEPAK 15 MONITOR/DEFIBRILLATOR 99577-0021662024-11-18
PHYSIO-CONTROL, INC.
 PEDIATRIC PADDLE, EXTERNAL 11133-0000082024-11-18
PHYSIO-CONTROL, INC.
 STANDARD HARD PADDLES 11130-0001432024-11-18
PHYSIO-CONTROL, INC.
 11998-000326 11998-0003262024-10-28
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Monitor/Defibrillator 70335-0002082024-09-12
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Monitor/Defibrillator 70335-0002092024-09-12
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Monitor/Defibrillator 70335-0002102024-09-12
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Monitor/Defibrillator 70335-0002112024-09-12
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Monitor/Defibrillator 70335-0002122024-09-12
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Monitor/Defibrillator 70335-0002132024-09-12
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Monitor/Defibrillator 70335-0002142024-09-12
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Monitor/Defibrillator 70335-0002152024-09-12
PHYSIO-CONTROL, INC.
 LIFEPAK 15 Monitor/Defibrillator 99577-001937U2024-08-22
PHYSIO-CONTROL, INC.
 LIFEPAK 20e Defibrillator/Monitor 99507-000133U2024-08-22
PHYSIO-CONTROL, INC.
 LIFEPAK 20e Defibrillator/Monitor 99507-000132U2024-08-22
PHYSIO-CONTROL, INC.
 LIFEPAK 20e Defibrillator/Monitor 99507-000122U2024-08-22
PHYSIO-CONTROL, INC.
 LIFEPAK 15 Monitor/Defibrillator 99577-001930U2024-08-22
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Monitor/Defibrillator 99335-0000132024-07-08
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Monitor/Defibrillator 99335-0000282024-07-08
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Monitor/Defibrillator 99335-0000292024-07-08
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Monitor/Defibrillator 99335-0000302024-07-08
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Monitor/Defibrillator 99335-0000322024-07-08
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Monitor/Defibrillator 99335-0000332024-07-08
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Monitor/Defibrillator 99335-0000342024-07-08
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Monitor/Defibrillator 99335-0000312024-07-05
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Monitor/Defibrillator 70335-0000362024-07-04
PHYSIO-CONTROL, INC.
 Invasive Pressure Adapter Cable, ICU 11230-0000212024-06-28
PHYSIO-CONTROL, INC.
 ASSY, CABLE, ADAPTER, TEMPERATURE, LP35, 6FT 11230-0000222024-06-28
PHYSIO-CONTROL, INC.
 ASSY, CABLE, ADAPTER, TEMPERATURE, LP35, 10FT 11230-0000232024-06-28
PHYSIO-CONTROL, INC.
 ASSY, CABLE, ADAPTER, IP, EDWARDS, LP35 11230-0000242024-06-28
PHYSIO-CONTROL, INC.
 ASSY, CABLE, ECG, 5 WIRE, AHA, 8 FT 11111-0000292024-06-28
PHYSIO-CONTROL, INC.
 ASSY, CABLE, ECG, 12LEAD, 6 WIRE PRECORDIAL, AHA 11111-0000392024-06-28
PHYSIO-CONTROL, INC.
 ASSY, CABLE, ECG, 12LEAD, 6 WIRE PRECORDIAL, IEC 11111-0000402024-06-28
PHYSIO-CONTROL, INC.
 CHARGER, BATTERY, LP35 11140-0001022024-06-28
PHYSIO-CONTROL, INC.
 ASSY, CABLE, THERAPY, LP35 11113-0000072024-06-28
PHYSIO-CONTROL, INC.
 SHIP KIT, POWER SUPPLY,LP35 41335-0000012024-06-28
PHYSIO-CONTROL, INC.
 KIT, PRINTER, LP35 11335-0000052024-06-28
PHYSIO-CONTROL, INC.
 LIFEPAK 20e Defibrillator/Monitors 96507-000005U2024-06-28
PHYSIO-CONTROL, INC.
 LIFEPAK 20e Defibrillator/Monitors 96507-000004U2024-06-28
PHYSIO-CONTROL, INC.
 LIFEPAK 20e Defibrillator/Monitors 96507-000006U2024-06-28
PHYSIO-CONTROL, INC.
 100MM ECG PAPERECG, UDI 11240-0000322024-06-12
PHYSIO-CONTROL, INC.
 50MM WIDE ECG PAPERRECORDING, UDI 11240-0000312024-06-11
PHYSIO-CONTROL, INC.
 LUCAS 99576-000063U2024-06-10
PHYSIO-CONTROL, INC.
 LUCAS CHEST COMPRESSION SYSTEM 99576-000043U2024-06-10
PHYSIO-CONTROL, INC.
 LIFEPAK 1000 defibrillator 99425-000025U2024-06-10
PHYSIO-CONTROL, INC.
 LIFEPAK 15 monitor/defibrillator 96577-000021U2024-06-07
PHYSIO-CONTROL, INC.
 LIFEPAK 15 monitor/defibrillator 96577-000022U2024-06-07
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Defibrillator/Monitor 70335-0000352024-06-06
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Defibrillator/Monitor 70335-0000372024-06-06
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Defibrillator/Monitor 70335-0000382024-06-06
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Defibrillator/Monitor 70335-0000392024-06-06
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Defibrillator/Monitor 70335-0000402024-06-06
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Defibrillator/Monitor 70335-0000412024-06-06
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Defibrillator/Monitor 70335-0000422024-06-06
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Defibrillator/Monitor 70335-0000432024-06-06
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Defibrillator/Monitor 70335-0000442024-06-06
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Defibrillator/Monitor 70335-0000452024-06-06
PHYSIO-CONTROL, INC.
 LIFEPAK 35 Defibrillator/Monitor 70335-0000462024-06-06
PHYSIO-CONTROL, INC.
 LIFEPAK 1000 defibrillator 99425-000025U2024-05-13
PHYSIO-CONTROL, INC.
 EDGE SYSTEM 11996-0000172023-07-06
PHYSIO-CONTROL, INC.
 EDGE SYSTEM 11996-0000912023-07-06
PHYSIO-CONTROL, INC.
 EDGE SYSTEM 11996-0000902023-07-06
PHYSIO-CONTROL, INC.
 Emergency Response Kit 11998-0003342023-03-20
PHYSIO-CONTROL, INC.
 ELECTRODE ASSY-QUIK-COMBO 11103-0000232023-02-28
PHYSIO-CONTROL, INC.
 CHARGE-PAK Charging Unit & 2 QUIK-PAK Electrodes 11403-0000012023-02-28
PHYSIO-CONTROL, INC.
 Replacement Kit for CHARGE-PAK battery charger 11403-0000022023-02-28
Physio-Control. Inc.
 QUIK-COMBO® Therapy Cable (a necessary AED accessory of the LIFEPAK® 15 Monitor/Defibrillator)2021-09-15
Physio-Control. Inc.
 LIFEPAK 15 Monitor/Defibrillator2021-06-23
Physio-Control. Inc.
 LIFEPAK 15 Monitor/Defibrillator2021-06-22
Physio-Control, Inc
 LIFEPAK® CR2 Defibrillator2021-06-08
Physio-Control. Inc.
 LIFEPAK® 1000 Defibrillator2021-04-27
Physio-Control. Inc.
 LIFEPAK 15 Monitor/Defibrillator and LIFEPAK 20e Defibrillator/Monitor2021-03-19
Physio-Control, Inc
 LIFEPAK CR2 Automated External Defibrillator2021-02-16
PHYSIO-CONTROL, INC.
 11141-000100 11141-0001002020-12-10
PHYSIO-CONTROL, INC.
 EDGE SYSTEM 11996-0000932020-11-10
PHYSIO-CONTROL, INC.
 QUIK-STEP 11103-0000262020-10-23
PHYSIO-CONTROL, INC.
 11101-000021 11101-0000212020-10-23
Physio-Control, Inc
 LIFEPAK CR2 Defibrillator2020-10-22
Physio-Control, Inc
 LIFEPAK CR2 Defibrillator2020-10-07
Physio-Control, Inc
 LIFEPAK CR2 Automated External Defibrillator2020-10-04
PHYSIO-CONTROL, INC.
 11110-000067 11110-0000672020-09-24
PHYSIO-CONTROL, INC.
 11110-000066 11110-0000662020-09-24
PHYSIO-CONTROL, INC.
 11111-000017 11111-0000172020-09-24
PHYSIO-CONTROL, INC.
 11111-000016 11111-0000162020-09-24
PHYSIO-CONTROL, INC.
 11110-000030 11110-0000302020-09-24
PHYSIO-CONTROL, INC.
 11110-000029 11110-0000292020-09-24
Physio-Control, Inc
 LIFEPAK CR2 Automated External Defibrillator2020-09-17
Physio-Control. Inc.
 LIFEPAK Automated External Defibrillators2020-09-16
Physio-Control, Inc
 LIFEPAK CR2 Defibrillator2020-08-27
PHYSIO-CONTROL, INC.
 11131-000040 11131-0000402020-08-14
PHYSIO-CONTROL, INC.
 11131-000041 11131-0000412020-08-14
PHYSIO-CONTROL, INC.
 11131-000042 11131-0000422020-08-14
PHYSIO-CONTROL, INC.
 11131-000043 11131-0000432020-08-14
PHYSIO-CONTROL, INC.
 11131-000044 11131-0000442020-08-14
PHYSIO-CONTROL, INC.
 11131-000045 11131-0000452020-08-14
PHYSIO-CONTROL, INC.
 11131-000046 11131-0000462020-08-14
PHYSIO-CONTROL, INC.
 11131-000047 11131-0000472020-08-14
Physio-Control. Inc.
 LIFEPAK Automated External Defibrillators (AEDs)2020-06-18
Physio-Control, Inc
 LIFEPAK CR2 Automated External Defibrillator (AED)2020-05-20
Physio-Control. Inc.
 LIFEPAK CR Plus defibrillator and LIFEPAK EXPRESS defibrillator2020-05-13
Physio-Control. Inc.
 LIFEPAK Automated External Defibrillators (AEDs)2020-02-13
PHYSIO-CONTROL, INC. [STRYKER CORP.]
QUIK-PAK Electrodes2020-02-07
PHYSIO-CONTROL, INC.
 11141-000115 11141-0001152020-02-06
PHYSIO-CONTROL, INC.
 11140-000052 11140-0000522020-02-06
Physio-Control. Inc.
 LIFEPAK Automated External Defibrillators (AEDs)2020-01-17
Physio-Control. Inc.
 LIFEPAK 20e defibrillator/monitor2019-11-25
Physio-Control. Inc.
 LIFEPAK 20e Defibrillator/Monitor2019-10-25
Physio-Control, Inc
 LIFEPAK® CR2 Defibrillator2019-10-23
PHYSIO-CONTROL, INC.
 11131-000010 11131-0000102019-09-25
PHYSIO-CONTROL, INC.
 11131-000011 11131-0000112019-09-25
PHYSIO-CONTROL, INC.
 11131-000012 11131-0000122019-09-25
PHYSIO-CONTROL, INC.
 11131-000013 11131-0000132019-09-25
PHYSIO-CONTROL, INC.
 11131-000014 11131-0000142019-09-25
PHYSIO-CONTROL, INC.
 11131-000024 11131-0000242019-09-25
PHYSIO-CONTROL, INC.
 11131-000023 11131-0000232019-09-25
PHYSIO-CONTROL, INC.
 11131-000022 11131-0000222019-09-25
PHYSIO-CONTROL, INC.
 11131-000021 11131-0000212019-09-25
PHYSIO-CONTROL, INC.
 11131-000019 11131-0000192019-09-25
PHYSIO-CONTROL, INC.
 11131-000001 11131-0000012019-09-24
PHYSIO-CONTROL, INC.
 LIFEPAK 15 monitor/defibrillator 41577-0002892019-07-22
PHYSIO-CONTROL, INC.
 LIFEPAK 15 monitor/defibrillator 41577-0002902019-07-22
PHYSIO-CONTROL, INC.
 LIFEPAK 15 monitor/defibrillator 41577-0002922019-07-22
Physio-Control. Inc.
 LIFEPAK Automated External Defibrillators (AEDs)2019-07-10
PHYSIO-CONTROL, INC. [STRYKER CORP.]
Sterilizable Internal Defibrillation Paddles2019-06-10
Physio-Control, Inc.
Sterilizable Internal Defibrillation Paddles For Use With LIFEPAK Defibrillators/monitors2019-06-03
Physio-Control. Inc.
 LIFEPAK Automated External Defibrillators (AED)2019-05-17
Physio-Control. Inc.
 LIFEPAK® 20e defibrillator/monitor2019-05-09
Physio-Control, Inc
 LIFEPAK CR2 Defibrillator2019-05-02
Physio-Control. Inc.
 LIFEPAK 15 monitor/defibrillator2019-03-24
Physio-Control, Inc
 LIFEPAK® CR2 Defibrillator2019-02-19
Physio-Control, Inc
 LIFEPAK CR2 Defibrillator2019-02-19
Physio-Control. Inc.
 LIFEPAK Automated External Defibrillators (AEDs)2019-01-22
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LIFEPAK CR2 Electrode Replacement Kit2019-01-10
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LIFEPAK CR2 Defibrillator, QUIK-STEP Pacing/ECG Defibrillation Electrodes, LIFEPAK CR2 Lithium Battery2019-01-10
Physio-Control, Inc
 LIFEPAK® CR2 Defibrillator2018-12-21
Physio-Control. Inc.
 LIFEPAK 15 monitor/defibrillator2018-12-06
Physio-Control. Inc.
 LIFEPAK Automated External Defibrillatorts (AEDs)2018-10-31
Physio-Control. Inc.
 LIFEPAK 15 Monitor/Defibrillator2018-08-06
PHYSIO-CONTROL, INC. [STRYKER CORP.]
QUIK-COMBO defibrillation cable (for use with the LIFEPAK 20 and LIFEPAK 20e Defibrillator/Monitor)2018-07-10
PHYSIO-CONTROL, INC. [STRYKER CORP.]
QUIK-COMBO Therapy Cable (for use with the LIFEPAK 15 Monitor/Defibrillator)2018-07-10
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LIFEPAK Lithium-Ion Rechargeable Battery (for use with the LIFEPAK 15 Monitor/Defibrillator)2018-07-10
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LIFEPAK 20e Defibrillator/Monitor2018-07-10
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LIFEPAK 20 Defibrillator/Monitor (Refurbished)2018-07-10
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LIFEPAK 15 Monitor/Defibrillator2018-07-10
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LIFEPAK 1000 Rechargeable Lithium-ion Battery2018-07-10
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LIFEPAK 1000 Nonrechargeable Lithium Manganese Dioxide Battery2018-07-10
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LIFEPAK 1000 Defibrillator2018-07-10
Physio-Control. Inc.
 LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE2018-07-02
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LIFEPAK EXPRESS Defibrillator2018-01-04
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LIFEPAK CR Plus Defibrillator2018-01-04
PHYSIO-CONTROL, INC. [STRYKER CORP.]
CHARGE-PAK Battery Charger2018-01-04
Physio-Control. Inc.
 LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger2017-12-21
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LUCAS BATTERY, DARK GRAY2017-12-13
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LUCAS ANTI SLIP, SLIM BACK PLATE2017-12-13
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LUCAS 32017-12-13
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LUCAS Power Supply with Cord2017-12-13
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LUCAS PCI Back Plate2017-12-13
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LUCAS Car Cable 12V2017-12-13
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LUCAS Battery Charger with Cord2017-12-13
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LUCAS Back Plate Grip Tape2017-12-13
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LUCAS 22017-12-13
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LUCAS 2 Battery2017-12-13
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LUCAS2017-12-13
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LUCAS2017-12-13
PHYSIO-CONTROL, INC. [STRYKER CORP.]
PEDIATRIC QUIK PACE NONINVASIVE PACING ELECTRODES2017-11-13
PHYSIO-CONTROL, INC. [STRYKER CORP.]
TrueCPR Coaching Device2017-11-13
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LIFEPAK 15 MONITOR/DEFIBRILLATOR V22017-11-13
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LIFEPAK 12 DEFIBRILLATOR/MONITOR ACCESSORIES2017-11-13
PHYSIO-CONTROL, INC. [STRYKER CORP.]
LIFEPAK 500 Accessories2017-11-13
PHYSIO-CONTROL, INC. [STRYKER CORP.]
INFANT/CHILD REDUCED ENERGY DEFIBRILLATION ELECTRODES2017-11-13
PHYSIO-CONTROL, INC. [STRYKER CORP.]
INFANT/CHILD REDUCED ENERGY DEFIBRILLATION ELECTRODES2017-11-13
PHYSIO-CONTROL, INC.
LIFEPAK 15 Monitor/defibrillator2014-12-19
PHYSIO-CONTROL, INC.
LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR2013-08-21
PHYSIO-CONTROL, INC.
TRUECPR COACHING DEVICE2013-04-17
PHYSIO-CONTROL, INC.
LIFEPAK 1000 DEFIBRILLATOR2012-10-11
PHYSIO-CONTROL, INC.
LIFEPAK 15 MONITOR/DEFIBRILLATOR2011-03-22
PHYSIO-CONTROL, INC.
LIFEPAK 122010-12-22
PHYSIO-CONTROL, INC.
LIFENET SYSTEM2010-11-05
PHYSIO-CONTROL, INC.
LIFENET SYSTEM2010-01-12
PHYSIO-CONTROL, INC.
LIFEPAK 15 MONITOR/DEFIBRILLATOR2009-03-11
PHYSIO-CONTROL, INC.
LIFEPAK 20E2008-07-29
PHYSIO-CONTROL, INC.
PERSONAL DEFIBRILLATOR1984-10-26

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Related Finance Registrations
NCAGE Code28494PHYSIO-CONTROL, INC.!DBA PHYSIO CONTROL
CAGE Code28494PHYSIO-CONTROL, INC. PHYSIO CONTROL STRYKER MEDICAL - EMERGENCY CARE
S.A.M. Registration28494 [9251992]PHYSIO-CONTROL, INC. PHYSIO CONTROL
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
202009265849Pusan,South Korea -> Seattle, WashingtonPCB ASSY125 CTN
202009249960Singapore,Singapore -> Tacoma, WashingtonPCB ASSY77 CTN
202009211157Shanghai ,China (Mainland) -> Seattle, WashingtonPCB ASSY73 CTN
2020091723154Singapore,Singapore -> Tacoma, WashingtonPCB ASSY77 CTN
202009171265Singapore,Singapore -> Tacoma, WashingtonLPCRT AED TRAINER AHA-GRP90 CTN
20200904923Gothenburg,Sweden -> New York/Newark Area, Newark, New JerseyPARTS FOR LUCAS DEVICE627 PKG
2020090448588Kaohsiung,China (Taiwan) -> Los Angeles, CaliforniaPHYSIO DISCOVERY TRUECPR PACKA3 CTN
2020090434640Kaohsiung,China (Taiwan) -> Los Angeles, CaliforniaPHYSIO DISCOVERY TRUECPR PACKA3 CTN
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