8 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DURACON MONOLITHIC STABILIZER FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150751·K-WIRE - SINGLE TROCAR 1.25mm DIA x 200mm
KODAKEKTACHEM DTR MODULE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SMART SCALE X-RAY PLATFORM
FDA 510(k)
FDA Class 1
·General Hospital
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 10, 2011
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·July 23, 2014
INTELECT XT
FDA Adverse Event
Malfunction
·CHATTANOOGA GROUP·Product code GZJ·October 24, 2007
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015