14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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iFuse Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
AGXO
FDA UDI
Oticon A/S·05707131282392·H160V2 TI, BTE 13 WL 85 TC AGXO
U-BALLOON DILATION CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CEROX, MODEL 321OF
FDA 510(k)
FDA Class 2
·Cardiovascular
BD MULTI-CHECK CD4 LOW CONTROL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 29, 2023
INCEPTA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 8, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 6, 2013
AUGMENTED INSERT
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code KWA·June 29, 2011
DIVA
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 7, 2020
DIVA
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 7, 2020
GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 12, 2017
SENRI
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code DQY·December 25, 2016
BD MULTI-CHECK CD4 LOW CONTROL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 16, 2023
METACROSS RX PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·October 15, 2019