7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
NATURE'S CRADLE MODEL C1500
FDA 510(k)
FDA Class 2
·General Hospital
Angel Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
FX DETACHABLE COIL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
2520274-2013-10183
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code MNI·February 11, 2013
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code NJE·January 14, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 28, 2014
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024