7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OLYMPUS INFANT RESECTOSCOPE AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LUHR MICRO MESH
FDA 510(k)
FDA Class 2
·Dental
TDX PHENCYCLIDINE II ASSAY
FDA 510(k)
FDA Unclassified
·Unknown
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·June 4, 2014
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·January 9, 2013
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·November 22, 2010
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