10 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MIS Bunion System
FDA 510(k)
FDA Class 2
·Orthopedic
INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550
FDA 510(k)
FDA Class 2
·Cardiovascular
VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
FDA 510(k)
FDA Class 2
·Hematology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 25, 2024
STEP DRILL, FOR 3.0MM KNOTLESS SUTURE TAK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HTW·February 17, 2017
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 21, 2013
COULTER LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code GKZ·July 28, 2011
GE OEC 9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 19, 2008
INTELLIVUE MX500 PATIENT MONITOR
FDA Adverse Event
Death
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·December 4, 2023
STEP DRILL, FOR 3.0MM KNOTLESS SUTURE TAK
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HTW·February 17, 2017