16 results
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20ms
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Sources: EU EUDAMED, US FDA
ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS
FDA 510(k)
FDA Class 1
·Ophthalmic
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575256792·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575256846·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575256839·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575256808·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575256822·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575256785·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575256815·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575256853·Articulating Surfaces, CCK
AMBULO 2400
FDA 510(k)
FDA Class 2
·Cardiovascular
Ventix Link Knotless Anchor with Inserter
FDA 510(k)
FDA Class 2
·Orthopedic
WECK HEMOCLIP APPLIER, MED 8" CVD
FDA Adverse Event
Injury
·TELEFLEX MEDICAL·Product code FZP·October 19, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 30, 2014
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 19, 2012
Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, Model Number 722005. 3. Allura Xper FD20, Model Number 722006. 4. Allura Xper FD20 Biplane, Model Number 722008. 5. Allura Xper FD10, Model Number 722010. 6. Allura Xper FD10/10, Model Number 722011. 7. Allura Xper FD20, Model Number 722012. 8. Allura Xper FD20 Biplane, Model Number 722013. 9. Allura Xper FD20 OR Table, Model Number 722023. 10. Allura Xper FD10, Model Number 722026. 11. Allura Xper FD10/10, Model Number 722027. 12. Allura Xper FD20, Model Number 722028. 13. Allura Xper FD20/10, Model Number 722029. 14. Allura Xper FD20 OR Table, Model Number 722035. 15. Allura Xper FD20/20, Model Number 722038. 16. Allura Xper FD20/15, Model Number 722058. 510(k) Numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025