26 results · 23ms · Sources: EU EUDAMED, US FDA

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hekaDrill

FDA 510(k)
FDA Class 2 ·Neurology

BIODENTA DENTAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA

FDA 510(k)
FDA Class 2 ·Radiology

MULTI SPECT 2 [510(K) K913630]

FDA Adverse Event
Other ·SIEMENS MEDICAL SYSTEMS·Product code IYX·April 13, 2001

THE PROMETRA CATHETER

FDA Adverse Event
FLOWONIX MEDICAL·Product code LKK·June 21, 2013

ARCHITECT C-PEPTIDE REAGENT

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JKD·August 5, 2011

RESERVOIR 3ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 22, 2014

GMK PRIMARY TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 26, 2026

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 9, 2022

FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 12, 2018

LASSOSTARNAV,10P,15MM DIA LOOP

FDA Adverse Event
Injury ·BIOSENSE WEBSTER INC·Product code DRF·February 22, 2023

LASSOSTAR CATHETER

FDA Adverse Event
Death ·BIOSENSE WEBSTER INC.·Product code DRF·December 30, 2020

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 20, 2019

GMK SPHERE FEMORAL COMPONENT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 22, 2017

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

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

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 27, 2020

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/20MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 13, 2020

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2019

3005180920-2018-00587

FDA Adverse Event
Injury ·July 31, 2018

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 LEFT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 13, 2017