25 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RESORBABLE NO PROFILE SCREW AND WASHER
FDA 510(k)
FDA Class 2
·Orthopedic
HI-TORQUE WINN
FDA UDI
ABBOTT VASCULAR INC.·08717648156847·HT WINN 80 Guide Wire .014" x 300 cm
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033405963·
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033405949·
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033405987·
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033405932·
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033405956·
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033405970·
MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT
FDA 510(k)
FDA Class 2
·Neurology
IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
FDA 510(k)
FDA Class 1
·Dental
INSET I
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 26, 2025
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 24, 2025
PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code BTO·April 26, 2017
PORTEX® BIVONA® UNCUFFED NEONATAL TRACHEOSTOMY TUBE
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code BTO·April 13, 2017
BIVONA® UNCUFFED PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.·Product code JOH·August 18, 2016
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 19, 2013
MEDISENSE OPTIUM
FDA Adverse Event
Injury
·Product code NBW·March 9, 2011
INDURA
FDA Adverse Event
Malfunction
·RICE CREEK MANUFACTURING·Product code LKK·March 12, 2008
BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE
FDA Adverse Event
Injury
·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code JOH·February 29, 2024
BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.·Product code BTO·August 15, 2016