7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
CERYX6, 611, CERYX 3 311 & CERYX 1 111
FDA 510(k)
FDA Class 3
·Cardiovascular
TOTAL IRON UIBC/TIBC ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
UROLOGICAL KIT W/STERILE, WATER-FILL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TOTAL ASR ACET IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. - 8010379·Product code KWA·June 3, 2014
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 16, 2012
TRUETRACK
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·June 11, 2015
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013