8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SPECIMEN COLLECTION DEVICE
FDA 510(k)
FDA Class 1
·Pathology
equilibrium®
FDA UDI
DENTAURUM GmbH & Co.KG·J011780049000·equilibrium® ti -12°Torque, +2°Angulation,18 r...
VASCUVIEW ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
LDH ISOTROL T
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 10, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 3, 2013
PRECISION OPTIUM EZ
FDA Adverse Event
Injury
·Product code NBW·August 2, 2010
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025