8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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END TIDAL CO2 TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
Propeller Sensor Model 2015-E
FDA 510(k)
FDA Class 2
·Anesthesiology
EXACTECH EQUINOXE SHOULDER STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 26, 2019
CAPSURE SP
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
VIRTUOSO VR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·October 8, 2010
M2A-MAGNUM 42-50MM TPR INSRT-6
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·December 7, 2012
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