13 results
·
19ms
·
Sources: EU EUDAMED, US FDA
STRYKER 5000
FDA 510(k)
FDA Class 2
·General Hospital
PEDICRAGT BASSINET
FDA 510(k)
FDA Class 2
·General Hospital
VOYAGE
FDA 510(k)
FDA Class 2
·Anesthesiology
ITREL 3
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code LGW·December 3, 2010
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 30, 2013
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 23, 2014
UNKNOWN ULTRABUTTON DEVICE
FDA Adverse Event
Injury
·ARTHROCARE CORPORATION·Product code MBI·August 11, 2023
UNKNOWN SMITH+NEPHEW DEVICE
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MAI·August 29, 2023
UNKNOWN ULTRABUTTON DEVICE
FDA Adverse Event
Injury
·ARTHROCARE CORPORATION·Product code MBI·August 11, 2023
UNKNOWN SMITH+NEPHEW DEV
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·August 30, 2023
UNKNOWN SMITH+NEPHEW DEV
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·August 24, 2023
UNKNOWN ULTRABUTTON DEV
FDA Adverse Event
Injury
·ARTHROCARE CORPORATION·Product code MBI·August 25, 2023
UNKNOWN SMITH+NEPHEW DEV
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HWC·August 21, 2023