9 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LANTOR CUBE STERILIZER TEST PACK
FDA 510(k)
FDA Class 2
·General Hospital
Arthrex®
FDA UDI
ARTHREX, INC.·00888867472440·Cortical Screw, 2.7 mm x 56 mm
Arthrex®
FDA UDI
ARTHREX, INC.·00888867046962·LO-PRO SCRW TM SS 2.7X 56MMCORTEX
MyoStrain 5.1
FDA 510(k)
FDA Class 2
·Radiology
RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 10, 2014
SC7000
FDA Adverse Event
Malfunction
·DRAEGER MEDICAL SYSTEMS, INC. (IT/M)·Product code MHX·October 22, 2010
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·December 20, 2012
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 9, 2015