10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TRICON M TIBIAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
PS-843242
FDA UDI
PATHEN MEDICAL LLC·00850005864615·24GX .56" IV CATHETER PURSAFETY S
MedSource Catheters
FDA UDI
MEDSOURCE INTERNATIONAL LLC·00840155411494·TrueSafe Comfort 24G x 0.56"
Smith's Catheters
FDA UDI
MEDSOURCE INTERNATIONAL LLC·00840155411296·Truesafe Comfort (PUR Catheter), 24G x 0.56"
Rebel 3DKNEE System
FDA 510(k)
FDA Class 2
·Orthopedic
TRIAGE TOX DRUG SCREEN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·June 2, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·November 21, 2012
SYNCHRON® LX20 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·September 24, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021