7 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BRAWN AND GROSHONG CATHETERS
FDA 510(k)
FDA Class 2
·General Hospital
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Polux , Minerva and Atropos PTA Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014
BELOTERO BASIC (INJECTION)
FDA Adverse Event
Other
·ANTEIS S.A.·Product code LMH·November 26, 2012
SMARTPUMP DUAL CHANNEL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KCY·September 22, 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