8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
VENOUS PRESSURE MONITOR, MF 35 LF
FDA 510(k)
FDA Class 2
·Cardiovascular
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515205963·Screwdriver, Phillips
Encompass 15 Channel Head Coil, 3T
FDA 510(k)
FDA Class 2
·Radiology
VISION TOOLS
FDA 510(k)
FDA Class 2
·Radiology
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·May 5, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code NVY·October 15, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 22, 2015
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025