7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
PELVX DONUT, PELVX CUBE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE
FDA 510(k)
FDA Class 2
·Cardiovascular
SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST.
FDA 510(k)
FDA Class 2
·Anesthesiology
AXON ECLIPSE CONTROLLER
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code GWF·February 19, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 1, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021