7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CANTROL URINE DIPSTICK CONTROL TWO LEVELS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS
FDA 510(k)
FDA Class 2
·Immunology
Alphatec Navigation Instruments
FDA 510(k)
FDA Class 2
·Neurology
SYMBIQ DUAL CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 3, 2014
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 5, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·December 3, 2012
Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.
FDA Enforcement
Class II
·Terminated·Alcon Research, LLC·October 21, 2020