8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
DURALASTIC II
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704286229·
EXACTECH BIPOLAR HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
COPPER VAPOR LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·February 11, 2013
OT ULTRAMINI
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 10, 2011
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. TAIWAN·Product code INI·July 24, 2014
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
FDA Enforcement
Class I
·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021