9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
RETRACTOR, GERBODE STERNAL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110638·COAXIAL IRR-ASP TIP STR W/SILICONE 0.3MM
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110683·LUER ADAPTOR FOR IRRIGATION
VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702
FDA 510(k)
FDA Class 2
·Hematology
LIAISON HAV IgM, LIAISON Control HAV IgM
FDA 510(k)
FDA Class 2
·Microbiology
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code KPE·September 26, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 19, 2013
RADIATION THERAPY
FDA Adverse Event
Death
·UNK·Product code IYE·July 13, 2010
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025