8 results
·
34ms
·
Sources: EU EUDAMED, US FDA
UPSHER FIBERBRITE LARYNGOSCOPE
FDA 510(k)
FDA Class 1
·Anesthesiology
KHEIRON® Spinal Fixation System, including patient specific K-ROD
FDA 510(k)
FDA Class 2
·Orthopedic
SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INTERCEED* (TC7) ABSORBABLE ADHESION BARRIER
FDA Adverse Event
Injury
·ETHICON INC.·Product code MCN·May 27, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·November 14, 2012
SINGLE LUMEN PRESSURE MONITORING SET
FDA Adverse Event
Malfunction
·COOK, INC.·Product code DQO·September 8, 2010
M2A MAGNUM MODULAR HEAD 50MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 28, 2016
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024