32 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P
FDA 510(k)
FDA Class 2
·Anesthesiology
Bur PM2-70 80K FC Ø2.5x80 St
FDA UDI
Bien-Air Surgery SA·17630055519839·
Oticon
FDA UDI
Oticon A/S·05707131164216·K14, RITE CNB
NITANIUM® SUPER ELASTIC ARCHWIRES
FDA UDI
Ortho Organizers, Inc.·00190707060183·.020 LOWER NITANIUM® SUPER ELASTIC OVAL ARCH FO...
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383501156·Gutta Percha Points is used to root canal filin...
ENDOSKELETON® TCS
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00191375032069·Rigid Container System Tray
ALERE DETERMINE HIV 1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ALERE SCARBOROUGH INC.·Product code MZF·December 13, 2018
ALERE DETERMINE HIV 1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ALERE SCARBOROUGH INC.·Product code MZF·February 19, 2019
MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ORTHOCEPH OC100 D
FDA 510(k)
FDA Class 2
·Dental
ALERE DETERMINE HIV-1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·December 3, 2019
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 3, 2013
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code MDS·May 2, 2011
THROMBUSTER II
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code MMY·March 17, 2014
SPYSCOPE DS II ACCESS & DELIVERY CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 30, 2020
SPYSCOPE DS II ACCESS & DELIVERY CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 23, 2020
THROMBUSTER II
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code DXE·October 23, 2012
THROMBUSTER II
FDA Adverse Event
Malfunction
·KANEKA CORP.·Product code DXE·December 21, 2012
THROMBUSTER II
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code DXE·January 16, 2019