12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
A-Oss
FDA 510(k)
FDA Class 2
·Dental
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837088705·
TRIOSYN T40 ANTIMICROBIAL WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
HEADWAY 17 ADVANCED MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
OUTLOOK
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL, INC·Product code FRN·June 1, 2012
PENUMBRA SMART COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·December 11, 2015
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014
SPRINT QUATTRO
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LWS·June 7, 2013
DUROM ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 28, 2011
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016