13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYRINGE INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
Bioseal Inc.
FDA UDI
BIOSEAL·00630094689012·Vaginal Speculum Clear w/ Light Wrapped
Mini Snake Fixation Arm
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896105225·Mini Snake Fixation Arm
INTER FIX™ Threaded Fusion Device
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978071961·12X20MM INTER FIX LC W/END CAP
FORZA
FDA UDI
Orthofix US LLC·18257200077052·THREADED INSERT
REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106
FDA 510(k)
FDA Class 2
·Cardiovascular
VINNO 8, VINNO 6, VINNO 5
FDA 510(k)
FDA Class 2
·Radiology
ACCU-CHEK ® SPIRIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·June 24, 2014
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 29, 2010
RIATA PASSIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·December 28, 2012
Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
FDA Recall
Terminated
·Bioplate Inc·Product code JEY·September 12, 2006
Bivona Aire-Cuf Endotracheal Tube
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·November 3, 2021
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012