8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
PATTERN DISCRIMINATION PERIMETER
FDA 510(k)
FDA Class 1
·Ophthalmic
VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FLOW-PAC CALCIUM REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 16, 2014
CELL-DYN EMERALD DILUENT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·October 19, 2010
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FMG·December 14, 2012
MINIPOLYAXIAL SCREWDRIVER
FDA Adverse Event
Injury
·DEPUY SPINE INC·Product code HXX·March 13, 2020
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024