22 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SmartAdjust Technology
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NEODENT IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
CONTOUR® PLUS BLUE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 12, 2026
VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 8, 2025
DOUBLE MOBILITY LINER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·April 30, 2026
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·November 20, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 22, 2013
VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 5, 2026
CONTOUR® CARE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 3, 2025
CONTOUR® CARE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 23, 2026
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025
AMISTEM-P COLLARED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·October 29, 2025
CONTOUR® NEXT
FDA Adverse Event
Injury
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 8, 2025
CONTOUR® PLUS ELITE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 8, 2025
DM CONVERTER ¿ TIN COATED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 31, 2026
MECTACER BIOLOX OPTION HEADS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 7, 2025
VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 30, 2026
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds
FDA Enforcement
Class II
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026