7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
DELFIA DIGOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ESOPHAGEAL OBTURATION AIRWAY
FDA 510(k)
FDA Class 2
·Anesthesiology
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·November 2, 2012
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 4, 2010
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