39 results · 22ms · Sources: EU EUDAMED, US FDA

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CARDIO VISION MICS AORTIC CLAMPS

FDA 510(k)
FDA Class 2 ·Cardiovascular

6 CHANNEL BODY COIL

FDA 510(k)
FDA Class 2 ·Radiology

GMK RESUFACING PATELLA SIZE 4

FDA 510(k)
FDA Class 2 ·Orthopedic

QUANTA SYSTEM S. P. A.

FDA Adverse Event
Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·December 9, 2014

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 13, 2023

PCA MTK REV TIB INS LT MED16MM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 22, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014

INRATIO

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·June 9, 2011

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 13, 2021

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 5, 2020

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 18, 2025

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 28, 2020

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 27, 2019

GMK PRIMARY TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2026

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 28, 2022

GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6 LEFT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 24, 2017

GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 11, 2020

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/26MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 14, 2023

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 4, 2023

AlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

FDA Recall
Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016