10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SCX SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Philips Medical Systems Hsg·00884838022164·
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862120220·Standard Band, Tooth 45/35, Size 20/Roth 22
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011862120180·Standard Band, Tooth 45/35, Size 20/Roth 18
Scope-Assist Flushing Sink
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CISBIO RENIN RIA TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 10, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 8, 2010
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·November 29, 2012
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