12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Treace Medical Concepts(TMC) Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550223·GENUMEDI PT KNEE SUP SILVER R EW VII
PRECISIONGLIDE NEEDLE 16 G X 1
FDA Adverse Event
Malfunction
·BD·Product code FMI·November 19, 2018
UCENTUM
FDA 510(k)
FDA Class 2
·Orthopedic
ULTRASONIC SCALER
FDA 510(k)
FDA Class 2
·Dental
BD PRECISIONGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·December 28, 2018
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 6, 2014
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 3, 2013
SYNCHRON® SYSTEMS RHEUMATOID FACTOR (RF) REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DHR·June 29, 2011
POWERHEART G5 AUTOMATIC AED
FDA Adverse Event
Malfunction
·CARDIAC SCIENCE CORPORATION·Product code MKJ·October 18, 2018
BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·February 12, 2019
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
FDA Enforcement
Class II
·Terminated·Steris Corporation·September 5, 2012