7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VX120 Ophthalmic Diagnostic Device
FDA 510(k)
FDA Class 2
·Ophthalmic
DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SOMATOM RESPIRATORY GATING
FDA 510(k)
FDA Class 2
·Radiology
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORTION·Product code LZG·May 29, 2013
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 23, 2014
OCTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 23, 2011
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012