8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
CHEMSTRIP CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
High-speed air turbine handpiece / Low-speed air turbine handpiece
FDA 510(k)
FDA Class 1
·Dental
INOMAX DS (DELIVERY SYSTEM)
FDA 510(k)
FDA Class 2
·Anesthesiology
DA VINCI SI SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL,INC.·Product code NAY·April 30, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 26, 2007
CASHMERE 14 - PLATINUM MICROCOIL
FDA Adverse Event
Injury
·MICRUS ENDOVASCULAR, LLC·Product code HCG·October 11, 2012
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025