7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
AUTOREF LENSMETER RL-10
FDA 510(k)
FDA Class 1
·Ophthalmic
DRESSER ARGUS P/N 1818
FDA 510(k)
FDA Class 2
·Anesthesiology
ABBOTT SMART CAP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 22, 2013
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 10, 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