7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STA-VWF CALIBRATOR KIT
FDA 510(k)
FDA Class 2
·Hematology
MICROALBUMINURIA ASSAY
FDA 510(k)
FDA Class 2
·Immunology
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·February 14, 2013
GENESIS IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 13, 2011
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·July 16, 2014
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·September 26, 2019