10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
EQUINOX CO2 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
R 72
FDA 510(k)
FDA Class 2
·Radiology
X-SUIT NIR COVERED BILIARY METALLIC STENT
FDA Adverse Event
Malfunction
·MEDINOL LTD.·Product code FGE·December 27, 2017
ZOOM CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 24, 2013
CARPENTIER-EDWARDS PERIMOUNT® MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·September 30, 2014
CAPSURE SENSE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
FDA Enforcement
Class III
·Terminated·Illumina Inc·December 31, 2014
Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.
FDA Enforcement
Class II
·Terminated·Medical Components, Inc dba MedComp·June 15, 2016
Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.
FDA Recall
Terminated
·Medical Components, Inc dba MedComp·Product code DYB·May 5, 2016