8 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
COCCIDIODES (COCCI)
FDA 510(k)
FDA Class 2
·Microbiology
SYNCHRON® AMYLASE (AMY) REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JFJ·September 21, 2010
IV CATHETER HUB
FDA 510(k)
FDA Class 2
·General Hospital
IBEX SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 5, 2014
ATTAIN ABILITY
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 15, 2012
C-ARM
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 6, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025