10 results
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17ms
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Sources: EU EUDAMED, US FDA
MONITRAL S
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PREMIER® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074229072·PLATE 6861230 30MM FSP ANTERIOR CRV
EndoEssentials™ Gutta Percha Points ISO#30 .02 Taper w MM Markings
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172014618·Polymer-based endodontic gutta percha
VECTORS TEMPORARY ANCHORAGE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
NuVasive Lumbar Interbody Implants
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·November 2, 2012
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code LXH·September 30, 2010
Vanguard XP Tibial Tray 79 mm Item # 195252
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
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