9 results
·
24ms
·
Sources: EU EUDAMED, US FDA
RIA KIT, LH
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG
FDA 510(k)
FDA Class 2
·Microbiology
Vivid E80, Vivid E90, Vivid E95
FDA 510(k)
FDA Class 2
·Radiology
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 30, 2014
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 11, 2012
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·August 3, 2010
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code NIU·August 28, 2014
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code NIU·August 28, 2014
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025