8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
FLEX-LOOP FLEXIBLE EAR CORETTE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209106660·
Genesys Spine TiLock2 Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
GE OEC ALTITUDE
FDA 510(k)
FDA Class 2
·Radiology
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KOG·June 5, 2014
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·November 30, 2012
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 28, 2010
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024