7 results
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20ms
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Sources: EU EUDAMED, US FDA
DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315
FDA 510(k)
FDA Class 1
·Anesthesiology
Equinoxe® Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
FDA 510(k)
FDA Class 2
·Cardiovascular
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·June 10, 2014
TRILOGY 202
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·December 5, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 22, 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