10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
TRIMMORE ELECTION BEAUTIFIER
FDA 510(k)
FDA Class 1
·Physical Medicine
NA
FDA UDI
Richard Wolf GmbH·04055207038895·NASAL FORCEPS WL 103MM W 2.5MM by Weil-Blakesl...
ESOP CO-CR FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
AERODR X70
FDA 510(k)
FDA Class 2
·Radiology
GXL NUETRAL LINER, G0 28MM ID
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·June 24, 2024
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 16, 2014
UNK
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 25, 2012
ENDOPATH ENDOSCOPIC LINEAR CUTTER, 45MM REGULAR
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GDW·August 9, 2007
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
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