14 results
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25ms
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Sources: EU EUDAMED, US FDA
FLAME PHOTOMETER STANDARD
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PREMIER® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490519281·CASE 1860501 GENERIC BASE PREMIER
LEONE SPA
FDA UDI
LEONE SPA·08033707032489·WEB 1ST MOLAR BANDS n.LR 1
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78605011·Sprint II Bracket Roth .022" max. 4+5 right w. ...
Stainless Steel Wire
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746049774·WIRE SS POSTED 018 X 025 22MM FORM I 10/PK
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78605011001·Sprint II Bracket Roth .022" max. 4+5 right w. ...
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78605010051·Sprint II Bracket Roth .022" max. 4+5 right w. ...
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78605010101·Sprint II Bracket Roth .022" max. 4+5 right w. ...
Noxilizer Surgical Ruler
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
IMPLANTIUM II
FDA 510(k)
FDA Class 2
·Dental
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 15, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 7, 2010
STRATA II VALVE, REGULAR
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·December 5, 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