8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
HEMATOLOGY CALIBRATOR CONTROL
FDA 510(k)
FDA Class 2
·Hematology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209126514·
BARD CO2 SURGICAL LASER SYS SLS-50/100
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MDx-Chex for BCN
FDA 510(k)
FDA Class 2
·Microbiology
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM INC·Product code MDS·June 6, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·December 3, 2012
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·September 3, 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