10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE
FDA 510(k)
FDA Class 2
·Orthopedic
Atlas Spine Expandable Cervical Standalone Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
ABX PENTRA TPU CAL, MODEL A11A01898
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WALLSTENT RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 21, 2025
EBI ARRAY SPINAL SYSTEM
FDA Adverse Event
Injury
·EBI·Product code MNI·January 15, 2008
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·March 7, 2013
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·February 15, 2011
CAPSURE Z NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·August 8, 2014
WALLSTENT? RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020