7 results
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34ms
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Sources: EU EUDAMED, US FDA
KAYE SCOOT-ABOUT, MODEL SB1
FDA 510(k)
FDA Class 1
·Physical Medicine
PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CD4 MONOCLONAL ANTIBODIES
FDA 510(k)
FDA Class 2
·Hematology
PINN CAN BONE SCREW 6.5MMX30MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NDJ·January 22, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·December 9, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·February 5, 2014
Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class I
·Terminated·Covidien·February 11, 2015