9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ISE/CI-
FDA 510(k)
FDA Class 2
·Clinical Chemistry
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471144330·PASSING PIN - DRILL TIP 2.4mm DIA x 385mm
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450282502·
TONOPORT V
FDA 510(k)
FDA Class 2
·Cardiovascular
BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ACRYSOF IQ TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD/ HUNTINGTON·Product code HQL·June 13, 2014
ON-Q PAIN PUMP
FDA Adverse Event
Injury
·I-FLOW, LLC·Product code MEB·January 8, 2013
MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES, INC.·Product code LWR·November 24, 2010
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016