26 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DynaCAD
FDA 510(k)
FDA Class 2
·Radiology
LEONE SPA
FDA UDI
LEONE SPA·08033707069607·POSTERIOR BAND REMOVING PLIERS LONG
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111024·INSTRUMENT CADDY MEDIUM
Sklar®
FDA UDI
SKLAR CORPORATION·10649111287329·HEANEY FCP 2X3 5.5" CROSS SERR
POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED)
FDA 510(k)
FDA Class 1
·General Hospital
INTEGRITY MODEL 1014284
FDA 510(k)
FDA Class 2
·Radiology
QUATTRO® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code NCX·August 6, 2024
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·February 28, 2019
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 7, 2021
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 11, 2021
MARYLAND DISSECTOR INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·March 18, 2014
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 20, 2013
COBAS E 601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·June 30, 2022
ANEURX
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR·Product code MIH·August 23, 2013
TALENT
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·August 23, 2013
ENDURANT
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·August 23, 2013
MEDTRONIC LEAD
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code DXY·July 22, 2019
MEDTRONIC LEAD
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·July 22, 2019