10 results
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18ms
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Sources: EU EUDAMED, US FDA
DU PONT DIMENSION C-REACTIVE PROTEIN METHOD
FDA 510(k)
FDA Class 2
·Immunology
NA
FDA UDI
STERIS CORPORATION·10724995152458·The Vis-U-All High Temperature Heat Seal Steril...
VERI/DFS TM #817
FDA 510(k)
FDA Class 2
·Neurology
MR8 Drill System, Midas Rex MR8 ClearView Tools
FDA 510(k)
FDA Class 2
·Neurology
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 9, 2014
LIGASURE IMPACT
FDA Adverse Event
COVIDIEN VALLEYLAB·Product code GEI·October 18, 2010
DEPTH GAUGE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HTJ·December 21, 2012
MIDAS REX MR8
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBC·May 9, 2025
MOTOR MR8 ELECTRIC
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·February 24, 2022
Vis-U-All High Temp 5"x15" Heat Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Enforcement
Class II
·Terminated·Steris Corporation·March 7, 2018