15 results · 21ms · Sources: EU EUDAMED, 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