8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLUOROSEAL, DENTIN SEALER AND CAVITY LINER
FDA 510(k)
FDA Class 2
·Dental
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331181429·kuntscher diamond pointed awl, w/ handle, 11" (...
G3(TM) Active Plate(R) Small Fragment System
FDA 510(k)
FDA Class 2
·Orthopedic
COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0
FDA 510(k)
FDA Class 2
·Radiology
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·June 10, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 7, 2010
LCS COMPLETE M/B PAT CEM LG+
FDA Adverse Event
Injury
·DEPUY (IRELAND)·Product code NJL·December 6, 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