14 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SpectoMed (v1.0)
FDA 510(k)
FDA Class 2
·Radiology
LC-DCP
FDA UDI
Synthes GmbH·10886982168252·2.7MM LC-DCP® PLATE 5 HOLES/50MM
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192817·20mm X 150mm Stem Pilot
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122315·KWire .094 x 9" (2.4x225mm)
Portex
FDA UDI
ICU MEDICAL, INC.·15019517076790·
MORELAND
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295123040·MORELAND REV INST CUP EXTRACTOR
BONE FUSION PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NuVasive X-CORE(R) Expandable VBR System
FDA 510(k)
FDA Class 2
·Orthopedic
PURE PECTUS
FDA UDI
KLS-Martin L.P.·00888118147158·PULLOUT TRAY, INSTRUMENTS, TOP
PURE PECTUS
FDA UDI
KLS-Martin L.P.·00888118147165·PULLOUT TRAY, INSTRUMENTS, BOTTOM
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·November 18, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
SIG MOD TIB TRAY CEM COCR 3
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 23, 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