10 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
BD NEXIVA SP WITH MAXZERO
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 28, 2025
AVIE A1C TEST SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD NEXIVA SP WITH MAXZERO
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 22, 2024
A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit
FDA Enforcement
Class I
·Terminated·Cardinal Health, Medical Products & Services·May 15, 2013
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·October 22, 2014
N/A
FDA Adverse Event
Injury
·STRYKER SUSTAINABILITY SOLUTIONS·Product code NQG·August 5, 2011
BIODESIGN SURGISIS TENSION FREE URETHRAL SLING
FDA Adverse Event
Injury
·COOK BIOTECH·Product code PAG·June 25, 2013
TAXUS LIBERTE PACLITAXEL ELUTING STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORP.·Product code NIQ·September 18, 2006