7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
TL 20W/12/RS & TL 40W/12/RS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STRATO PORT INTRODUCER KT(10 FR) LPS 5057/MODIFIED
FDA 510(k)
FDA Class 2
·General Hospital
ZEISS MULTIYAG LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NOVAMAX LINK GLUCOSE MONITOR
FDA Adverse Event
Other
·NOVA BIOMEDICAL CORP.·Product code NBW·June 27, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 30, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·December 3, 2010
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