8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3-WAY STOPCOCK
FDA 510(k)
FDA Class 2
·General Hospital
PARAMEDIC O2 KIT
FDA 510(k)
FDA Class 2
·Anesthesiology
MOLDEYE
FDA 510(k)
FDA Class 2
·Ophthalmic
FORCEPS MCL19BIS RIGHT BOUCHAYER HEART
FDA Adverse Event
Malfunction
·XOMED MICROFRANCE MFG·Product code KAE·April 30, 2014
TI HUMERAL STEM PRESS-FIT SIZE 10/125MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSD·October 4, 2012
UNIVERSAL INSERTER/EXTRACTOR
FDA Adverse Event
Injury
·ZHEJIANG BIOMET MEDICAL PRODUCTS CO., LTD·Product code HWB·May 19, 2015
Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). 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 17. Allura Xper FD20/15 OR Table, Model Number 722059.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025