11 results
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26ms
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Sources: EU EUDAMED, US FDA
METRACO EVOKED POTENTIAL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M75268212501·CUSTOM SURGICAL KIT
Cortera
FDA UDI
Surgalign Spine Technologies, Inc.·00840311233526·Tap, NAV, Cann, 12.5
MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD)
FDA 510(k)
FDA Class 2
·Dental
OP SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·September 22, 2021
ARTICUL/EZE BALL 28 +1.5 GR
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.-1818910·Product code JDI·May 20, 2014
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·November 6, 2012
EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·August 31, 2010
XP-CR Tibial Tray - Interlok 63mm Item # 195269
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
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