11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator
FDA 510(k)
FDA Class 2
·Cardiovascular
OsteoMed
FDA UDI
OSTEOMED LLC·00845694057257·U-Shape Cheek Retractor, ICON
Blue Beacon Submucosal Injectable Solution
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN
FDA 510(k)
FDA Class 2
·Microbiology
SYNCHROMED
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·November 11, 2008
SYNCHROMED
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·November 11, 2008
QUICK SET PARADIGM
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·November 2, 2009
PERFORMER INTRODUCER
FDA Adverse Event
Malfunction
·COOK, INC.·Product code DYB·September 18, 2014
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·August 8, 2011
ARTICUL/EZE M 36MM +8.5
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code JDI·July 2, 2013
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021