27 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXTREMITY MEDICAL HAMMERTOE DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AMS LARGE PORE POLYPROPYLENE MESH
FDA 510(k)
FDA Class 3
·Obstetrics/Gynecology
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 29, 2013
PENTA LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 16, 2011
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN-BENNETT CORP.·Product code CBK·August 20, 2008
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
HNM LATERAL ANCHOR
FDA Adverse Event
Injury
·HNM STAINLESS, LLC DBA HNM MEDICAL·Product code HWC·April 16, 2018
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
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 15, 2024
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 17, 2025