26 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
K032008
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LJT·May 31, 2007
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420320580·Anterio Lateral Wedge Osteotomy Guide, 32mm x 58mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710410320580·Anterior Closing Osteotomy Guide, 32mm x 58mm
STAT PROFILE PHOX PLUS L ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VECTORSURGE 5, MODEL VS-500
FDA 510(k)
FDA Class 2
·Physical Medicine
CONTOUR®
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 19, 2025
CONTOUR TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 31, 2012
BREEZE2
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·February 18, 2015
SYRINGE 20ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·October 17, 2023
CONTOUR NEXT
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·June 13, 2014
CONTOUR
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 5, 2019
CONTOUR® TS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 21, 2025
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 26, 2013
DERMABOND 2
FDA Adverse Event
Injury
·NI·Product code MPN·March 28, 2011
VENACURE NEVERTOUCH DIRECT
FDA Adverse Event
Malfunction
·ANGIODYNAMICS·Product code GEX·August 5, 2014
CONTOUR® TS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·August 21, 2025
CONTOUR® TS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025
CONTOUR®
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 13, 2025
UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 26016 Femoral Component Size 6, 26018 Femoral Component Size 8 and 26020 Femoral Component Size 10
FDA Recall
Terminated
·Plus Orthopedics USA·Product code HRY·July 18, 2006