169 results
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20ms
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Sources: EU EUDAMED, US FDA
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
FDA Pre-Market Approval
FDA Class 2
·MICUR-MIC SYSTEMS
PressON™
FDA UDI
NEXUS SPINE, L.L.C.·B6788200730·MIS Dilator #2
Surgical Direct
FDA UDI
Surgical Direct, Inc.·B382SD488200730·5 inch Chondro Pick, 25° Angled Tip, Curved
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209128792·
OPEN LOOP AMBULATORY INSULIN INFUSION
FDA 510(k)
FDA Class 2
·General Hospital
CAPIOX FX15 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·May 20, 2014
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD·Product code MCM·November 6, 2012
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·August 24, 2010
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P
PULSE GENERATOR, PERMANENT, IMPLANTABLE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVZ·June 9, 2016
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVZ·June 10, 2015
ADAPTA D
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVZ·June 10, 2015
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Injury
·MEDTRONIC, PLC·Product code DXY·March 27, 2015
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·June 9, 2015
PULSE GENERATOR, PERMANENT, IMPLANTABLE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVZ·March 27, 2015
PULSE GENERATOR, PERMANENT, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code NVZ·May 1, 2018
MEDTRONIC LEAD
FDA Adverse Event
Injury
·MEDTRONIC, PLC·Product code DXY·March 27, 2015
REVEAL XT
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DSI·August 9, 2016
ENRHYTHM
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code NVZ·December 23, 2014