7 results
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35ms
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Sources: EU EUDAMED, US FDA
MODULUS VERNI-TROL ANESTHETIC VAPORIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
Q LAB SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
Dynamic TiBase
FDA 510(k)
FDA Class 2
·Dental
M2A-MAGNUM PF CUP 52ODX46ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 20, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·September 28, 2012
12 FOOT EXTENSION SET EASYLOCK CONNECTOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 31, 2010
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