11 results
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22ms
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Sources: EU EUDAMED, US FDA
ENZYMUN-TEST FERRITIN
FDA 510(k)
FDA Class 2
·Immunology
PREMIER® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490482219·PLATE 6860137 37.5MM ANTERIOR CERVICAL
BIS
FDA UDI
Covidien LP·10884521657793·SIMULATOR SENSOR
ORTHOMED
FDA UDI
ORTHO-MED, INC.·B8038601370·BERTHA HIP RETRACTOR SERRATED UPSDIE TIP
TUBE, FEEDING, ARGYLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
PREMIER® ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·March 3, 2017
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·June 10, 2014
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK SE AND CO. KG·Product code NVZ·November 29, 2012
NAVILYST MEDICAL
FDA Adverse Event
Injury
·NAVILYST MEDICAL·Product code LJS·June 19, 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