7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSOR
FDA 510(k)
FDA Class 1
·General Hospital
PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
HEMASITE ACCESS MONITOR (TENT.) #RS-8200
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 7, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 31, 2012
CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code JXG·June 23, 2015
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