10 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PULPDENT UNO-DUO
FDA 510(k)
FDA Class 2
·Dental
FORCEPS CEV405 FENESTRATED 350MM JOHANN [MXI/XOM]
FDA Adverse Event
Injury
·XOMED MICROFRANCE MFG·Product code GEI·March 19, 2014
SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ORTHOPANTOMOGRAPH OP300
FDA 510(k)
FDA Class 2
·Dental
TI VECTRA(TM) PLATE 2 LEVEL/30MM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KWQ·March 7, 2013
WARM TOUCH COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN/ FORMERLY TYCO HEALTHCARE·Product code DWJ·January 6, 2011
CARELINK
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code KRG·August 8, 2014
BD SAFE-CLIP¿ NEEDLE CLIPPING & STORAGE DEVICE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·September 25, 2019
SHARPS DISPOSAL
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·August 16, 2019
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020