8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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syngo.MR Applications
FDA 510(k)
FDA Class 2
·Radiology
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
KITAZATO OPU NEEDLE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·June 27, 2023
DUROM US ACETABULAR COMPONENT 64/58 X
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·October 9, 2008
SPRINT QUATTRO SECURE S
FDA Adverse Event
Death
·MPRI·Product code LWS·June 27, 2013
UKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KXA·July 8, 2011
STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
FDA Recall
Terminated
·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011