8 results
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131ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BOND-III AUTOMATED SLIDE STAINER
FDA Adverse Event
Injury
·LEICA BIOSYSTEMS MELBOURNE PTY. LTD·Product code KPA·October 27, 2023
Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.
FDA Recall
Terminated
·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code JTS·March 23, 2018
FRONT LOADING SUPER-LOOP ELEC (BOX OF 5)
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC·Product code GEI·July 25, 2019
SHELL POROUS WITH CLUSTER HOLES
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·October 25, 2019
COCR FEMORAL HEAD
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code KWA·October 25, 2019
PROGAV SYS M.SA 20 U.CONTROL RESERVOIR
FDA Adverse Event
Injury
·CHRISTOPH MIETHKE GMBH & CO KG·Product code JXG·October 26, 2022
VAPR S90 4.0MM W/INTEGR HDP -EA
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code GEI·August 30, 2019
Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in
FDA Recall
Completed
·Ventana Medical Systems Inc·Product code KPA·October 4, 2019