9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
CURAGEL HYDROGEL WOUND DRESSING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Arthrex®
FDA UDI
ARTHREX, INC.·00888867406926·Humeral Spacer 33+12mm
Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator
FDA 510(k)
FDA Class 2
·Immunology
VAPORMAX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEARTSTART
FDA Adverse Event
Other
·LAERDAL MEDICAL, A.S.·Product code MKJ·July 13, 2006
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 8, 2013
UNKNOWN DEPUY FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTL., LTD.8010379·Product code KWA·July 22, 2014
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 6, 2011
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013