10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Rapid Neuro3D
FDA 510(k)
FDA Class 2
·Radiology
MISTAR, MODEL V3.2
FDA 510(k)
FDA Class 2
·Radiology
Nile Alternative Fixation
FDA 510(k)
FDA Class 2
·Orthopedic
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 12, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 11, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·July 23, 2013
CPS SHORT ANCHOR PLUG 14MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 14, 2019
CPS XS SHT SPDL W PINS 600LBF
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·July 23, 2019
CPS CENTERING SLEEVE 21MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KRO·July 23, 2019
Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 4, 2018