7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OSPREY Closed IV Catheter System (OspreyV2)
FDA 510(k)
FDA Class 2
·General Hospital
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
FDA 510(k)
FDA Class 2
·General Hospital
EXCELERON BACTERIAL FILTERS
FDA 510(k)
FDA Class 2
·Anesthesiology
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·November 13, 2008
HIRES 90K
FDA Adverse Event
Malfunction
·ADVANCED BIONICS, LLC·Product code MCM·August 15, 2011
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022