15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Annalise Enterprise CTB Triage Trauma
FDA 510(k)
FDA Class 2
·Radiology
ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MENTOR OBTAPE TRANS-OBTURATOR TAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·September 1, 2011
GYNECARE TVT-AA ABDOMINAL
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 17, 2013
VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 5, 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
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
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022