6 results
·
24ms
·
Sources: EU EUDAMED, US FDA
ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV
FDA 510(k)
FDA Class 1
·Clinical Toxicology
UroLift System UL400
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SINUS QUICK EB SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 5, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 7, 2014
MENISCAL CINCH, CURVED TIP
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code GAT·February 15, 2011