10 results · 26ms · Sources: EU EUDAMED, US FDA

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OXYGEN TUBINGS

FDA 510(k)
FDA Class 1 ·Anesthesiology

Tranquil-L™

FDA UDI
NEXUS SPINE, L.L.C.·B6788231420·The 2 Level Tray

CONPHAR VELCRO TOUNIGUER

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

Coltolux Comfort LED Curing Light

FDA 510(k)
FDA Class 2 ·Dental

HAKIM VALVE WITH INLINE RESERVOIR

FDA Adverse Event
Injury ·CODMAN & SHURTLEFF, INC.·Product code JXG·May 21, 2013

NC QUANTUM APEX?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 21, 2014

HI-TORQUE SPARTACORE GUIDE WIRE

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code DQX·November 7, 2012

ANTI-SIPHON PCA EXTENSION SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·September 1, 2010

HAKIM PROGRAMMABLE VALVE WITHOUT PRECHAMBER

FDA Adverse Event
Injury ·CODMAN & SHURTLEFF·Product code JXG·June 25, 2014

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