7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ELITE R 90/15
FDA 510(k)
FDA Class 2
·Radiology
POWDER FREE VINYL PATIENT EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
LIQUICHEK TDM CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
ON-Q PAIN PUMP
FDA Adverse Event
Injury
·I-FLOW, LLC·Product code MEB·January 8, 2013
ISOLATOR SYNERGY
FDA Adverse Event
Malfunction
·ATRICURE, INC.·Product code GEI·November 24, 2010
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 3, 2014
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