7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BAXTER SOLUTION ADMINISTRATION SETS
FDA 510(k)
FDA Class 2
·General Hospital
DIGITAL RADIOGRAPHY SYSTEM IDR-2000
FDA 510(k)
FDA Class 2
·Radiology
DSL CK-MB (DSL #3200)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEARTMATE II SYSTEM CONTROLLER
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·December 9, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 10, 2014
ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 14, 2012
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021