12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
FDA 510(k)
FDA Class 2
·Cardiovascular
BD Difco™ QC Antigen Salmonella O Group C1
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902213215·BD Difco™ QC Antigen Salmonella O Group C1
Luna
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205004406·Luna Opal R Mini .022 LL5 D/HK (-22°T 0°A)
NA
FDA UDI
Synthes GmbH·10886982156334·1.3MM EXTENDED H-PLATE/LEFT
COMPANION MODEL 221, 321, 421
FDA 510(k)
FDA Class 2
·Physical Medicine
ALARIS SMARTSITE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FPA·January 26, 2026
WRIST FUSION PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
HARD SHELL VENTED NASAL MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 3, 2014
4000CMS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·July 1, 2013
Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025