9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor
FDA 510(k)
FDA Class 2
·Radiology
HEPARIN ASSAY CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM)
FDA 510(k)
FDA Class 2
·Cardiovascular
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 15, 2011
FIBERED IDC OCCLUSION SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code KRD·June 11, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 9, 2008
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
GMK-HINGE FEMORAL COMPONENT SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·June 28, 2019
GMK-HINGE FIXED TIBIAL INSERT SIZE 1/26MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·July 12, 2019