8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)
FDA 510(k)
FDA Class 1
·Microbiology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756606165·ARTHROSCOPY PACK
TECHNICARE 280
FDA 510(k)
FDA Class 2
·Radiology
MECRON MRC-HEADLESS FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
GEMSTR 7 THPY ALT ST
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 25, 2014
840 VENTILATOR
FDA Adverse Event
Malfunction
·NELLCOR PURITAN BENNETT IRELAND·Product code CBK·December 27, 2012
ENDOTAK ENDURANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·November 9, 2010
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015