8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
BIVONA-COLORADO VOICE PROSTHESIS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
3M MODEL 8243 ITE HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
TYPE III DENTAL GOLD ALLOY FOR CROWN & BRIDGE APP.
FDA 510(k)
FDA Class 2
·Dental
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·June 12, 2014
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 15, 2013
REZOOM
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code MFK·December 6, 2010
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
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024