10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
THERMAL DILUTION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102404·ALIO SCIMITAR PRECHOPPER
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST
FDA 510(k)
FDA Class 2
·Orthopedic
ECHOENCODER
FDA 510(k)
FDA Class 2
·Radiology
COBAS 8000 C 702 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·December 13, 2024
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·February 10, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 14, 2012
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·September 3, 2010
HYPO NEEDLE 25G X 1 A BEV RP
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FMI·April 4, 2019
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023