13 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150
FDA 510(k)
FDA Class 2
·Cardiovascular
BIPOLAR PENCIL, MODEL 3901-002, 3900-002
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDTRADE PRODUCTS ALGINATE ISLAND
FDA 510(k)
FDA Unclassified
·Unknown
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Injury
·ANGIOMED GMBH & CO.·Product code FGE·November 21, 2008
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO.·Product code FGE·November 5, 2008
AXXENT FLEXISHIELD MINI (K090417)
FDA Adverse Event
Injury
·XOFT, INC.·Product code IXI·January 7, 2011
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code FGE·February 20, 2009
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO.·Product code FGE·November 4, 2008
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO, MEDIZINTECHNIK·Product code FGE·February 13, 2009
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·September 21, 2015
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 2, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·September 15, 2014
BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231621¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024