15 results
·
19ms
·
Sources: EU EUDAMED, US FDA
VENTREZYME T4U IMMUNOASSAY T4U
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CoRoent
FDA UDI
Nuvasive, Inc.·00887517376213·CoRoent Contoured Trial, 4L
FUSE ™ SPINAL SYSTEM
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169245556·CAGE 2841024 FUSE 10MM X 24MM 4DEG
ODOR MASKING AGENT IN BOUNDARY OBSTETRI.
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EXTERNAL PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
Zimmer, Inc.·00889024193406·
NA
FDA UDI
Zimmer, Inc.·00889024193376·
NA
FDA UDI
Zimmer, Inc.·00889024193420·
NA
FDA UDI
Zimmer, Inc.·00889024193383·
NA
FDA UDI
Zimmer, Inc.·00889024193413·
NA
FDA UDI
Zimmer, Inc.·00889024193390·
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·May 14, 2014
INFUSO.R.
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 20, 2012
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 12, 2015
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021