31 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Tasso+ Convenience Kit
FDA UDI
Tasso Inc.·00860006434588·Tasso+ convenience kit allows self-collection o...
Luxe™ 2.5 Semi-custom loupe
FDA UDI
METREX RESEARCH, LLC·00850036373605·Semi-custom loupe with Luxe™ 2.5 plano oculars,...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111368271·MAYO TRAY 15 1/8X 10 5/8X 3/4"
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383554374·Gutta Percha Points is used to root canal filin...
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383502184·Gutta Percha Points is used to root canal filin...
Sklar
FDA UDI
SKLAR CORPORATION·30649111041543·MAYO TRAY 15 1/8X10 5/8X3/4
Sklar®
FDA UDI
SKLAR CORPORATION·30649111313060·MAYOTRAY 15 1/8X10 5/8X3/4 PK6
NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8
FDA 510(k)
FDA Class 2
·Neurology
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·April 29, 2024
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·April 17, 2024
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 30, 2013
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 11, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·August 7, 2008
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
SURGIQUEST AIRSEAL
FDA Adverse Event
Injury
·SURGIQUEST, INC.·Product code GCJ·September 25, 2014
SURGIQUEST AIRSEAL
FDA Adverse Event
Injury
·SURGIQUEST, INC.·Product code GCJ·March 11, 2015
SURGIQUEST AIRSEAL
FDA Adverse Event
Other
·SURGIQUEST, INC.·Product code HIF·December 12, 2013
Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(A. Product packaged in a convenient manner for use in a general clinical procedure
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·April 19, 2017