7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
INTRODUCTION/DRAINAGE CATHETER & ACCESS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RECORDER, STRIP CHART WITH PRINTER
FDA 510(k)
FDA Class 1
·Cardiovascular
EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE
FDA 510(k)
FDA Class 2
·Radiology
16" CENTURY STERILIZER
FDA Adverse Event
STERIS MEXICO, S. DE R.L. DE C.V.·Product code FLE·June 18, 2014
NC SPRINTER RX BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code LOX·October 8, 2010
DEPUY ASR XL FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·December 20, 2012
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024