8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
WILLCOGEN MENINGITIDIS KIT ZL25
FDA 510(k)
FDA Class 2
·Microbiology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209105496·
Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)
FDA 510(k)
FDA Class 2
·Cardiovascular
MINIMATE COMPRESSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
PRIMEWIRE PRESTIGE PLUS
FDA Adverse Event
Malfunction
·VOLCANO S.R.L.·Product code DQX·April 18, 2014
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·November 29, 2012
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·September 29, 2010
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