7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PEDIATRIC HOSPITAL BED
FDA 510(k)
FDA Class 2
·Physical Medicine
MLP Special Locking Bone Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1
FDA 510(k)
FDA Class 2
·Radiology
ELUTIA WOUND DRAIN
FDA Adverse Event
Malfunction
·BACTERIN INTERNATIONAL INC.·Product code OEI·May 15, 2014
MARQUIS SERIES STOPCOCKS
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·October 8, 2010
RESOLUTE INTEGRITY RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·December 20, 2012
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024