10 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)
FDA 510(k)
FDA Class 2
·Physical Medicine
ELMED
FDA UDI
ELMED INCORPORATED·00842180148277·Yezerski Small Bone Rongeur, Small, Overall Len...
CEREBRALOGIK- AEEG
FDA 510(k)
FDA Class 2
·Neurology
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TDX FPIA ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·December 28, 2007
TDX FPIA ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·January 2, 2008
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014
NC QUANTUM APEX¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·September 1, 2011
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 17, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022