7 results
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17ms
·
Sources: EU EUDAMED, US FDA
PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
XANAR MODEL XSE-300 SMOKE EVACULATER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODEL XLE
FDA 510(k)
FDA Class 2
·Radiology
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·June 10, 2014
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 11, 2010
SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM INC.·Product code MDS·December 10, 2012
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015