8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
R1750 AND R1424 POWERED HEATING UNITS
FDA 510(k)
FDA Class 1
·Physical Medicine
OSTOMY KARAYA GUM POWDER
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
23 MM SINGLE-PEG PATELLA COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
ARTICUL/EZE BALL 28 +8.5 BL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·December 7, 2012
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 4, 2010
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 8, 2025
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012