10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SILVERLON CONTACT WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981299·anteriors; shade C3; mould CM4
DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA
FDA 510(k)
FDA Class 2
·Immunology
ITE HEARING AID, EAR-TRONICS MODELS: M1-M23
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
HEARTSTART MRX - EMS DEFIB
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 20, 2014
AUTOPULSE NIMH BATTERY
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·January 25, 2013
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·February 2, 2011
L.C. 5000/CE 2-CHANNEL PUMP (50/CASE)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·August 22, 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
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025