7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
COMPUR EASY TOUCH CHEMISTRY ANALYZER-
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PADSCAN HD SERIES BLADDER SCANNER
FDA 510(k)
FDA Class 2
·Radiology
LORDEX POWER TRACTION EQUIPMENT
FDA 510(k)
FDA Class 2
·Physical Medicine
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 23, 2014
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS·Product code GEX·November 6, 2012
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 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