9 results
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21ms
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Sources: EU EUDAMED, US FDA
DENTAL INSTRUMENTS - EXCAVATORS
FDA 510(k)
FDA Class 1
·Dental
Commonwealth Edison - Burn Bag
FDA UDI
Certified Safety Manufacturing, Inc.·00766588233185·Commonwealth Edison - Burn Bag
IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
I-FLOW ELASTOMERIC PUMP WITH BOLUS
FDA 510(k)
FDA Class 2
·General Hospital
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·July 8, 2019
ENTERALITE INFINITY ENTERAL FEEDING PUMP
FDA Adverse Event
Malfunction
·MOOG MED DEVICES GROUP·Product code LZH·February 28, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 7, 2012
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·August 30, 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