27 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Stat Profile Prime Plus Analyzer System
FDA 510(k)
FDA Class 2
·Hematology
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361014966·Screw Assy REset Solid 6.0X45mm Gen 3
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361014959·Screw Assy REset Solid 6.0X40mm Gen 3
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361014928·Screw Assy REset Solid 6.0X25mm Gen 3
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361014935·Screw Assy REset Solid 6.0X30mm Gen 3
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361014980·Screw Assy REset Solid 6.0X55mm Gen 3
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361014942·Screw Assy REset Solid 6.0X35mm Gen 3
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361014911·Screw Assy REset Solid 6.0X20mm Gen 3
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361014973·Screw Assy REset Solid 6.0X50mm Gen 3
MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SYNAPSE 3D LIVER ANALYSIS
FDA 510(k)
FDA Class 2
·Radiology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·November 4, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 19, 2022
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·November 15, 2019
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 13, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 11, 2025
COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code GKZ·July 27, 2011
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 4, 2013
INTERSTIM
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code EZW·September 29, 2008
ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·May 1, 2019