11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TM-300 TRACTION SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
INOMAX DS (DELIVERY SYSTEM), MODEL 10003
FDA 510(k)
FDA Class 2
·Anesthesiology
Potenza
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMP CBL DIA2 SS CABLE SLEEVE
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code JDQ·November 18, 2016
IMP CBL DIA2 SS CABLE SLEEVE
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code JDQ·November 18, 2016
IMP CBL DIA2 SS &CABLE SLEEV
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code JDQ·November 30, 2016
IMP CBL DIA2 SS & CABLE SLEEVE
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code JDQ·July 20, 2016
SM304 M-SERIES W/ZOOM
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code INK·March 7, 2013
INSYNC III
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code DXY·February 15, 2011
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 8, 2014
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024