7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
SOFT TISSUE ANCHORING SET KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LOOK IRRIGATING CYSTOTOMES
FDA 510(k)
FDA Class 1
·Ophthalmic
BECKMAN EPSILON(TM) PROLACTIN TEST KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MINI TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·June 16, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 19, 2010
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·December 14, 2012
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