10 results
·
17ms
·
Sources: EU EUDAMED, US FDA
HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC
FDA 510(k)
FDA Class 2
·Cardiovascular
EZ-OX PLUS GENERATION II
FDA 510(k)
FDA Class 1
·Anesthesiology
LALAN GLOVES (PVT) LTD GLOVE, PATIENT EXAMINATION, LATEX
FDA 510(k)
FDA Class 1
·General Hospital
BD VACUTAINER® SINGLE USE HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·December 6, 2017
DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DWF·December 15, 2016
12FR X1.5CM ENTRISTAR SLG X1
FDA Adverse Event
Other
·COVIDIEN·Product code KNT·January 22, 2013
ENDOSTAT ELECTROSURGICAL UNIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNS·December 17, 2010
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 14, 2014
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025