7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BOLUS DISPENSER
FDA 510(k)
FDA Class 2
·General Hospital
ARGENCO 52HN
FDA 510(k)
FDA Class 2
·Dental
TSRH CENTRAL POST HOOKS
FDA 510(k)
FDA Class 2
·Orthopedic
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 30, 2013
AMPLATZ SUPER STIFF GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code DQX·December 22, 2010
ENSEAL G2 CURVED JAW
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·July 15, 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