Philips Medical Systems

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1937850	1937850	Philips Medical Systems	1	N	2020-04-25	2039 Concourse Dr Saint Louis MO US 63146

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
86530	1688025296	K936084	OMNI WARM GEL PACKS	IMD	1994-03-31
86530	1219601004	K040044	HEEL SNUGGLER, MODEL 99047	MPO	2004-01-27
86530	1260044412	K010052	RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER	MQM	2001-03-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
MPO	1	2004-01-27
MQM	1	2001-03-19
IMD	1	1994-03-31

PMA#

HeartStart FRx Defibrillator (861304)
2021-11-15
Philips Medical Systems
HeartStart FRx Defibrillator (861304)
2021-09-24
Philips Medical Systems
HeartStart FRx Defibrillator
2021-06-15
Philips Medical Systems
HeartStart FRx Defibrillator
2021-06-15
Philips Medical Systems
HeartStart FRx Defibrillator
2021-03-10
Philips Medical Systems
HeartStart FRx Defibrillator
2021-02-12
Philips Medical Systems
HeartStart FRx Defibrillator
2020-12-16
Philips Medical Systems
HeartStart FRx Defibrillator
2020-08-22
Philips Medical Systems
HeartStart FRx Defibrillator
2020-08-03
Philips Medical Systems
HeartStart FRx Defibrillator (861304)
2020-07-16
Philips Medical Systems
HeartStart FRx Defibrillator
2020-05-11
Philips Medical Systems

PMN#

Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
2021-09-24
Philips Medical Systems
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
2021-09-08
Philips Medical Systems
Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph
2021-06-30
Philips Medical Systems
PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph
2020-09-29
Philips Medical Systems
Philips Biosensor BX100
2020-04-16
Philips Medical Systems
M3290B Patient Information Center IX
2019-08-06
Philips Medical Systems
MX40 Release C.01
2018-07-24
Philips Medical Systems
MX40 Release B.07
2017-11-09
Philips Medical Systems
M3290B Philips IntelliVue Information Center IX
2017-07-07
Philips Medical Systems
SureSigns VS3; SureSigns VS4
2017-03-31
Philips Medical Systems
CareEvent Inclusive Of The CareEvent Mobile Application Accessory
2016-06-24
PHILIPS MEDICAL SYSTEMS
M3290B Philips IntelliVue Information Center IX
2016-06-13
PHILIPS MEDICAL SYSTEMS
Philips Efficia CMS200 Central Monitoring System
2016-05-05
PHILIPS MEDICAL SYSTEMS
PATIENT MONITORS VARIOUS MODELS
2016-01-26
PHILIPS MEDICAL SYSTEMS
Philips CS770 IntelliSpace Critical Care And Anesthesia
2015-10-30
PHILIPS MEDICAL SYSTEMS
Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra Long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M
2015-10-27
PHILIPS MEDICAL SYSTEMS
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING
2015-01-23
PHILIPS MEDICAL SYSTEMS
CareEvent
2015-01-15
PHILIPS MEDICAL SYSTEMS
M3290B Philips IntelliVue Information Center IX
2014-12-03
PHILIPS MEDICAL SYSTEMS
PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION
2014-09-25
PHILIPS MEDICAL SYSTEMS
SURESIGNS VS3, SURESIGNS VS4
2014-06-26
PHILIPS MEDICAL SYSTEMS
CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION
2014-06-13
PHILIPS MEDICAL SYSTEMS
INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE
2013-10-23
PHILIPS MEDICAL SYSTEMS
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
2013-10-18
PHILIPS MEDICAL SYSTEMS
PHILIPS DXL 12/16-LEAD ECG ALGORITHM
2013-09-26
PHILIPS MEDICAL SYSTEMS
PHILIPS SURESIGNS CENTRAL
2013-08-12
PHILIPS MEDICAL SYSTEMS
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8
2013-04-18
PHILIPS MEDICAL SYSTEMS
HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST
2013-03-12
PHILIPS MEDICAL SYSTEMS
INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE
2013-03-06
PHILIPS MEDICAL SYSTEMS
DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)
2012-12-13
PHILIPS MEDICAL SYSTEMS
PAGEWRITER TC 20, 30, 50, 70
2012-04-03
PHILIPS MEDICAL SYSTEMS
PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES
2012-02-16
PHILIPS MEDICAL SYSTEMS
SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR
2012-02-14
PHILIPS MEDICAL SYSTEMS
INTELLIVUE MX40 PATIENT MONITOR
2011-11-17
PHILIPS MEDICAL SYSTEMS
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
2011-10-28
PHILIPS MEDICAL SYSTEMS
SURESIGNS VS2+ -SURESIGNS VSI
2011-10-11
PHILIPS MEDICAL SYSTEMS
MAMMODIAGNOST DR
2011-09-23
PHILIPS MEDICAL SYSTEMS
SURESIGNS VSI VITAL SIGNS MONITOR
2011-05-20
PHILIPS MEDICAL SYSTEMS
SURESIGNS VS2 VITAL SIGNS MONITOR
2011-05-20
PHILIPS MEDICAL SYSTEMS
PHILIPS ECG LEADWIRE SET
2011-02-15
PHILIPS MEDICAL SYSTEMS

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