8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BARD-PARKER CAROTID SHUNT
FDA 510(k)
FDA Class 2
·Cardiovascular
Flowable Wound Matrix
FDA 510(k)
FDA Unclassified
·Unknown
PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL E4C COLOR
FDA 510(k)
FDA Class 2
·Radiology
ADVISA DR MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 10, 2014
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE AND CO. KG·Product code NVZ·November 29, 2012
LX300, TURRET 300W
FDA Adverse Event
Malfunction
·INTEGRA LUXTEC·Product code KOG·September 21, 2010
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 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