9 results
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25ms
·
Sources: EU EUDAMED, US FDA
BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED.
FDA 510(k)
FDA Class 1
·Pathology
PREMIER® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074229225·PLATE 6861270 70MM FSP ANTERIOR CRV
EndoEssentials™ Gutta Percha Points ISO#70 .02 Taper w MM Markings
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172014670·Polymer-based endodontic gutta percha
IMMUNO-TEC II OT AGAROSE PLATE KIT
FDA 510(k)
FDA Class 1
·Immunology
CephSimulation
FDA 510(k)
FDA Class 2
·Radiology
PROTECTA XT VR
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code LWS·June 10, 2014
PROLENE POLYPROPYLENE SUTURE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAW·October 1, 2010
SM104 M-SERIES W/5TH WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 2, 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