10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VADER® Pedicle System, G21 Cement
FDA 510(k)
FDA Class 2
·Orthopedic
VIATRONIX V3D EXPLORER
FDA 510(k)
FDA Class 2
·Radiology
Monaco Rtp System
FDA 510(k)
FDA Class 2
·Radiology
ACTIVA PC
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·August 22, 2011
FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE
FDA Adverse Event
Malfunction
·ASSET MEDIKAL TASARIM SAN. TIC. A.S.·Product code FPA·July 24, 2025
ECHELON LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 4, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011
UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·July 12, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
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