20 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANCILLARY AND LARGE VOLUME SHARPS DISPOSAL CONTAINERS
FDA 510(k)
FDA Class 2
·General Hospital
EVOLUT FX DCS
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NPT·November 10, 2025
Equinoxe Mega Prosthesis
FDA 510(k)
FDA Class 2
·Orthopedic
FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments
FDA 510(k)
FDA Class 2
·Neurology
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973936·UniTip High Resolution Catheter 14F
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970959·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970935·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970942·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970911·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973028·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973806·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973240·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970966·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970928·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970973·
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 30, 2014
SWAN GANZ CCOMBO CONTINUOUS CARDIAC OUTPUT VIP CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DYG·January 30, 2013
FOUNDATION KNEE
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code JWH·December 14, 2010
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 3, 2019
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025