12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEONATE PERCUSSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490519373·CASE 1860510 PREMIER INS TRAY UPPER
Pearson Zirconia Blocks for Sirona InLab #5105
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724A8605101·
LEONE SPA
FDA UDI
LEONE SPA·08033707032571·WEB 1ST MOLAR BANDS n.LR 10
Shoreline ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981127527·16x14x10mm, 15 Degree Trial
Stainless Steel Wire
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746049866·WIRE SS POSTED 018 X 025 40MM FORM I 10/PK
DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MAKO 7
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 15, 2014
THINLINE
FDA Adverse Event
Injury
·GUIDANT ANGLETON/ST. PAUL·Product code NVN·October 7, 2010
SYNVISC (HYLAN G-F 20) INJECTION
FDA Adverse Event
Other
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·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