7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY
FDA 510(k)
FDA Class 2
·Orthopedic
SILICONE
FDA 510(k)HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
CPT HIP SYSTEM FEMORAL STEM
FDA Adverse Event
Malfunction
·ZIMMER·Product code JDI·April 18, 2014
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·October 12, 2010
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·December 14, 2012
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024