8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
POCKET SPIROMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MINILOK QUICKANCHOR PLUS
FDA 510(k)
FDA Class 2
·Orthopedic
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·May 23, 2014
LTV
FDA Adverse Event
Injury
·CAREFUSION 203, INC.·Product code CBK·November 1, 2012
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·September 7, 2010
MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
FDA Enforcement
Class II
·Terminated·Mentor Texas, LP.·January 21, 2015
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