Medical Device Manufacturer · US , Seattle , WA

Philips Medical Systems

107 submissions · 105 cleared · Since 2002
107
Total
105
Cleared
0
Denied

Philips Medical Systems — FDA 510(k) Submissions

Philips Medical Systems has submitted 107 FDA 510(k) premarket notifications since 2002, of which 105 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms), Automated External Defibrillators (non-wearable), Electrocardiograph, Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms), Oximeter . Use the specialty filter in the sidebar to narrow results.

107 devices
1–25 of 107
Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
K212704 · IYN System, Imaging, Pulsed... · Radiology
Sep 2021 29d
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
K211597 · IYN System, Imaging, Pulsed... · Radiology
Sep 2021 107d
Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph
K210560 · DPS Electrocardiograph · Cardiovascular
Jun 2021 125d
PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph
K191738 · DPS Electrocardiograph · Cardiovascular
Sep 2020 459d
Philips Biosensor BX100
K192875 · DRG Transmitters And... · Cardiovascular
Apr 2020 191d
M3290B Patient Information Center iX
K183387 · MHX Monitor, Physiological,... · Cardiovascular
Aug 2019 243d
MX40 Release C.01
K180017 · MHX Monitor, Physiological,... · Cardiovascular
Jul 2018 203d
MX40 Release B.07
K172226 · MHX Monitor, Physiological,... · Cardiovascular
Nov 2017 107d
M3290B Philips IntelliVue Information Center iX
K163584 · MHX Monitor, Physiological,... · Cardiovascular
Jul 2017 199d
SureSigns VS3; SureSigns VS4
K163649 · DSJ Alarm, Blood-pressure · Cardiovascular
Mar 2017 98d
CareEvent inclusive of the CareEvent Mobile Application accessory
K161164 · MSX System, Network And... · Cardiovascular
Jun 2016 60d
M3290B Philips IntelliVue Information Center iX
K153702 · MHX Monitor, Physiological,... · Cardiovascular
Jun 2016 173d
Philips Efficia CMS200 Central Monitoring System
K160951 · MHX Monitor, Physiological,... · Cardiovascular
May 2016 30d
PATIENT MONITORS VARIOUS MODELS
K151812 · MHX Monitor, Physiological,... · Cardiovascular
Jan 2016 208d
Philips CS770 IntelliSpace Critical Care and Anesthesia
K151366 · DXJ Display, Cathode-ray... · Cardiovascular
Oct 2015 162d
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
K152363 · DXQ Blood Pressure Cuff · Cardiovascular
Oct 2015 68d
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING
K133659 · MKJ Automated External... · Cardiovascular
Jan 2015 422d
CareEvent
K142935 · MSX System, Network And... · Cardiovascular
Jan 2015 98d
M3290B Philips IntelliVue Information Center iX
K143057 · MSX System, Network And... · Cardiovascular
Dec 2014 40d
PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION
K133603 · JAK System, X-ray,... · Radiology
Sep 2014 304d
SURESIGNS VS3, SURESIGNS VS4
K133961 · DSJ Alarm, Blood-pressure · Cardiovascular
Jun 2014 184d
CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION
K132524 · JAK System, X-ray,... · Radiology
Jun 2014 305d
INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE
K131590 · FPD Tube, Feeding · Gastroenterology & Urology
Oct 2013 145d
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
K130684 · MKJ Automated External... · Cardiovascular
Oct 2013 219d
PHILIPS DXL 12/16-LEAD ECG ALGORITHM
K132068 · DPS Electrocardiograph · Cardiovascular
Sep 2013 85d

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