8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
URIC-ACID
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Rampart-O
FDA UDI
SPINEOLOGY INC.·M7402813511·Rampart-O
XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ECHOSTAR SPICA 1.5T MR SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·March 26, 2014
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 2, 2015
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015