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Philips Health Care

FDA Regulatory Profile

Philips Health Care has 0 FDA recalls, 0 inspections, 20 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Aug 17, 2020

Updated: recalls Oct 23, 2026 · inspections Oct 23, 2026 · compliance actions Oct 23, 2026.

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Summary

Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K2013523D Auto LAAAug 17, 2020
K200974QLAB Advanced Quantification SoftwareJun 3, 2020
K200179Collaboration LiveFeb 18, 2020
K191647QLAB Advanced Quantification SoftwareDec 20, 2019
K192226Lumify Diagnostic Ultrasound SystemSep 6, 2019
K190913QLAB Advanced Quantification Software 13Jun 18, 2019
K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30…Oct 4, 2017
K171314QLAB Advanced Quantification SoftwareMay 30, 2017
K163020Xperius Ultrasound SystemNov 16, 2016
K162549Lumify Ultrasound SystemOct 3, 2016
K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemSep 14, 2016
K153480ClearVue850 Diagnostic Ultrasound SystemDec 16, 2015
K132087PERCUNAV SYSTEMJul 24, 2013
K130159QLAB QUANTIFICATION SOFTWARE HEART MODELMay 13, 2013
K121498PERCUNAVDec 14, 2012
K121638ST80I STRESS TEST SYSTEMJul 18, 2012
K120855INTELLISPACE ECGJun 29, 2012
K120321CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEMFeb 17, 2012
K112959CALG-STR EXERCISE ECG ANALYSIS ALGORITHMJan 26, 2012
K110151ACHIEVA R4 1.5T AND ACHIEVA R4 3.0TMar 22, 2011

FDA data resources