12 results
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33ms
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Sources: EU EUDAMED, US FDA
COOK PACEMAKER CORP. 115 UNIPOLAR CARDI
FDA 510(k)
FDA Class 3
·Cardiovascular
CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES
FDA 510(k)
FDA Class 2
·Cardiovascular
PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
FDA 510(k)
FDA Class 2
·General Hospital
NA
FDA UDI
Zimmer, Inc.·00889024194625·
NA
FDA UDI
Zimmer, Inc.·00889024194632·
NA
FDA UDI
Zimmer, Inc.·00889024194601·
NA
FDA UDI
Zimmer, Inc.·00889024194618·
ANALYTICAL E MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·November 22, 2010
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·May 31, 2014
SETROX S 60
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·November 15, 2012
OXIMAX N-595 PULSE OXIMETER
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DQA·August 20, 2010
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017