13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Real Time Image Gating System for Proton Beam Therapy Systems
FDA 510(k)
FDA Class 2
·Radiology
DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WART FREEZE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 15, 2024
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 14, 2013
TRIAGE CARDIAC PANEL 25 TEST
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code NBC·July 14, 2014
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 30, 2011
TRU CC FEMORAL SIZE 1 LEFT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 15, 2025
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 29, 2025
GMK-REVISION TIBIAL AUGMENTATION SIZE 2/10MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·June 23, 2023
GMK-HINGE FEMORAL COMPONENT SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·February 7, 2022
GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 29, 2019
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 4, 2019