7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SILICONE INSTRUMENT SHODS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PATIENT EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 25, 2014
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·January 3, 2013
RIATA PASSIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·November 10, 2010
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020