Philips Medical Systems
FDA 510(k) & PMA Approved Devices — 15 products
Total Devices15
Categories7
Latest FDA decision2026-05-21
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| PMA | P180028 | Automated external defibrillators (non-wearable) | MKJ | 2026-05-21 | View |
| 510(k) | K212704 | Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System | IYN | 2021-09-24 | View |
| 510(k) | K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | IYN | 2021-09-08 | View |
| 510(k) | K210560 | Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph | DPS | 2021-06-30 | View |
| 510(k) | K191738 | PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph | DPS | 2020-09-29 | View |
| 510(k) | K192875 | Philips Biosensor BX100 | DRG | 2020-04-16 | View |
| 510(k) | K183387 | M3290B Patient Information Center iX | MHX | 2019-08-06 | View |
| 510(k) | K180017 | MX40 Release C.01 | MHX | 2018-07-24 | View |
| 510(k) | K172226 | MX40 Release B.07 | MHX | 2017-11-09 | View |
| 510(k) | K163584 | M3290B Philips IntelliVue Information Center iX | MHX | 2017-07-07 | View |
| 510(k) | K163649 | SureSigns VS3; SureSigns VS4 | DSJ | 2017-03-31 | View |
| 510(k) | K161164 | CareEvent inclusive of the CareEvent Mobile Application accessory | MSX | 2016-06-24 | View |
| 510(k) | K153702 | M3290B Philips IntelliVue Information Center iX | MHX | 2016-06-13 | View |
| 510(k) | K160951 | Philips Efficia CMS200 Central Monitoring System | MHX | 2016-05-05 | View |
| 510(k) | K151812 | PATIENT MONITORS VARIOUS MODELS | MHX | 2016-01-26 | View |
No matching devices.