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Philips

Medical device makerAI in FinlandAI. FDA records under 2 spellings of its name, each linked to the record.

  • Records across the group: 3,984, 92 entitiesAI
  • 510(k) clearances: 2,002
  • Device recalls: 1,919
  • AI-enabled devices: 62
  • Warning letters: 1

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Philips and its 91 subsidiaries

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Sep 25, 2026EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemK262548 · IYN510(k) clearances
Sep 25, 2026Altis Full Face MaskK261262 · BZD510(k) clearances
Aug 7, 2026Zenition 30K254205 · OWB510(k) clearances
Aug 4, 2026Alturion Series Diagnostic Ultrasound SystemK262311 · IYN510(k) clearances
Jul 30, 2026dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TK262330 · MOS510(k) clearances
Jul 27, 2026Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound SystemK261211 · IYN510(k) clearances
Jul 24, 2026dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TK262294 · MOS510(k) clearances
Jun 29, 2026Alturion Series Diagnostic Ultrasound SystemK260667 · IYN510(k) clearances
Jun 29, 2026Alturion Series Diagnostic Ultrasound SystemK260667 · RadiologyAI-enabled devices
Jun 26, 2026Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.Class II · Potential of failing to trigger clinical scan during Bolus Tracking.Device recalls
May 27, 2026EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsK260680 · RadiologyAI-enabled devices
May 27, 2026EPIQ Series Diagnostic Ultrasound SystemK260123 · RadiologyAI-enabled devices
May 5, 2026Lumify Diagnostic Ultrasound SystemK252558 · RadiologyAI-enabled devices
Mar 27, 2026Spectral CT Verida FamilyK253649 · RadiologyAI-enabled devices
Mar 27, 2026EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemK253595 · RadiologyAI-enabled devices
Mar 23, 2026CT Rembra RT; CT Areta RT; CT RembraK252992 · RadiologyAI-enabled devices
Mar 17, 2026EchoNavigator R5.0K253614 · RadiologyAI-enabled devices
Dec 3, 2025Philips Incisive CTClass II · Potential for incomplete scan due to unstable connection inside of floating sensor.Device recalls
Dec 23, 2022Incisive CT, model 728143 & 728144 running Software Version 5.0.0.Class II · Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orieDevice recalls
Feb 24, 2021Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) appliClass II · Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couDevice recalls
May 16, 2019Warning letter: Medical DevicesCDRHWarning letters

Subsidiaries and Divisions

91 firms in the Philips group, most records first

Canada and Imports

Across the Philips group, matched by company name
Active Health Canada device licences
350, as of Nov 10, 2026
FDA import refusals since 2024
20 shipment lines, through Oct 23, 2026

Names and Identifiers

Appears as
Philips OYPhilips Oy
Wikidata
Q170416

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.