11 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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APPENDIX EXTRACTOR 8385.50
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Holder
FDA UDI
ADLER ORTHO SPA·08050507136933·CONDYLES HOLDER ASSEMBLY FOR UNIVERSAL HANDLE
NANOBEAM 940, MODEL 940-900-02
FDA 510(k)
FDA Class 2
·Physical Medicine
S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·September 3, 2025
KINECTIV TECHNOLOGY MODULAR NECK
FDA Adverse Event
Injury
·ZIMMER INC·Product code JDI·December 23, 2010
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 16, 2013
COBAS 6000 E601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code MMI·July 17, 2014
TOTAL KNEE REPLACEMENT
FDA Adverse Event
Malfunction
·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·November 10, 2016
PATIENT SPECIFIC TOTAL FEMUR
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·August 15, 2018