8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SERALUTE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110652·COAXIAL IRR-ASP TIP 45 DEG W/ SILICONE
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CARAFE, PERSONAL, 1-QT SEMI-RECTANGULAR
FDA 510(k)ARCHITECT I2000SR ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·September 26, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 19, 2013
HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC. MEDOS S.A.·Product code JXG·July 14, 2010
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025