10 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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The Progressive Orthopaedic Total Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158216648·FORCEPS TENACULUM SCHROEDER STRAIGHT 9.5"
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331186776·ragnell (kilner) scissors, straight, 5 1/8" (13...
ProLift
FDA UDI
Life Spine, Inc.·00190837086176·
PHARMACARIBE INHALED SALINE SOLUTIONS
FDA 510(k)
FDA Class 2
·Anesthesiology
HYDROGUM 5
FDA 510(k)
FDA Class 2
·Dental
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 30, 2013
FINELINE II
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVN·July 6, 2011
CRYSTALENS
FDA Adverse Event
Injury
·EYEONICS, INC.·Product code HQL·September 4, 2008
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