7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABBOTT XL3M INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
2006, 2010, 2011, 2012(CARDIAC DC DEFIBRILLATOR)
FDA 510(k)
FDA Class 2
·Cardiovascular
MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code NVN·February 9, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 23, 2014
CONTAK RENEWAL TR
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NKE·January 7, 2011
McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data.
FDA Recall
Terminated
·McKesson Israel Ltd. Or Towers Bldg. B 4, Nehoshet St. Tel Aviv Israel·Product code DQK·March 12, 2018