27 results · 38ms · Sources: EU EUDAMED, US FDA

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Harioculture TL-16 Time-lapse Incubator

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

FlexCath Select Steerable Sheath (10 French)

FDA 510(k)
FDA Class 2 ·Cardiovascular

WELL LEAD TRACHEOSTOMY TUBE

FDA 510(k)
FDA Class 2 ·Anesthesiology

GMK TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 20, 2025

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R E-CROSS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2023

LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 58/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·September 29, 2023

GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/10 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 31, 2024

GMK TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 21, 2026

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2024

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L TINBN COATED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 28, 2023

GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 3 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 21, 2023

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

PINNACLE MTL INS NEUT40IDX58OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·November 11, 2014

COULTER® LH 500 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·September 10, 2011

RESTORE SENSOR

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 23, 2013

GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 5 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 4, 2024

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L TINBN COATED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 18, 2024

GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 4+ L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 13, 2024

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 19, 2023

STEM: AMISTEM P 01.18.413 AMISTEM-P LAT STEM SIZE 3

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 7, 2023