8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
PHENOBARBITAL TEST SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PHILIPS HeartStart FR3 with Text and Small Soft Case
FDA UDI
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION·00884838051454·FR3 Text, US English, Small Soft Bundle
APEXCAL
FDA 510(k)
FDA Class 2
·Dental
BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 6, 2012
CAPSURE SP
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
WARM TOUCH II COMPACT WARMING UNIT
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DWJ·September 24, 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