7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LACTATE DEHYDROGENASE (LDH) REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PROGUIDE NEEDLE SET
FDA 510(k)
FDA Class 2
·Radiology
Electronic Sphygmomanometer
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPSURE SENSE
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
LUMAX 340 HF-T
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG.·Product code MRM·November 5, 2012
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 22, 2015
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