23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE
FDA 510(k)
FDA Class 2
·Neurology
SlimLine®
FDA UDI
ZIMMER SPINE, INC.·00889024403642·
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20320541·BioFinisher wires Straight-Arch-F. max. .017"x....
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0310540·T-Handle, Primal, 1/4 inch Square, Cannulated
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420320540·Anterio Lateral Wedge Osteotomy Guide, 32mm x 54mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710410320540·Anterior Closing Osteotomy Guide, 32mm x 54mm
X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1
FDA 510(k)
FDA Class 2
·Cardiovascular
FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312
FDA 510(k)
FDA Class 2
·Cardiovascular
PENUMBRA SYSTEM SEPARATOR 032
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code NRY·March 12, 2014
PENUMBRA SYSTEM SEPARATOR 032
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code NRY·March 12, 2014
PENUMBRA SYSTEM REPERFUSION CATHETER 054
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code NRY·March 12, 2014
PENUMBRA SYSTEM REPERFUSION CATHETER 032
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code NRY·March 12, 2014
PENUMBRA SYSTEM SEPARATOR 054
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code NRY·March 12, 2014
PENUMBRA SYSTEM REPERFUSION CATHETER 032
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code NRY·March 12, 2014
COLORADO 2 SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·January 22, 2009
COLORADO 2 SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 23, 2012
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 6, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·March 28, 2011
SYNCARDIA FREEDOM DRIVER
FDA Adverse Event
Malfunction
·SYNCARDIA SYSTEMS, INC.·Product code LOZ·August 4, 2014
UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 26016 Femoral Component Size 6, 26018 Femoral Component Size 8 and 26020 Femoral Component Size 10
FDA Recall
Terminated
·Plus Orthopedics USA·Product code HRY·July 18, 2006