46 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
×
Molecular Transport Media - MTM
FDA 510(k)
FDA Class 2
·Microbiology
CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS
FDA 510(k)
FDA Class 2
·Radiology
ANTI-HUMAN LEU-2A (CD8) PE
FDA 510(k)
FDA Class 2
·Hematology
ANTI-HUMAN LEU-3A (CD4) FITC
FDA 510(k)
FDA Class 2
·Hematology
ANTI-LEU-12 B CELL REAGENT
FDA 510(k)
FDA Class 2
·Hematology
CTS-200 WITH EZU-PL21 TRANSDUCER
FDA 510(k)
FDA Class 2
·Radiology
KAISHOU VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ANTI-LEU-4 FITC LYSIN C BUFFER
FDA 510(k)
FDA Class 2
·Hematology
SP-CL Hip Stem and LCU Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
cobas® liat CT/NG nucleic acid test
FDA 510(k)
FDA Class 2
·Microbiology
CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)
FDA 510(k)
FDA Class 2
·Cardiovascular
CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
FDA 510(k)
FDA Class 2
·Cardiovascular
LUBi Water Based Personal Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
cobas® liat CT/NG/MG nucleic acid test
FDA 510(k)
FDA Class 2
·Microbiology
FloNavi Open Field Fluorescence Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID
FDA 510(k)
FDA Class 2
·Cardiovascular
V*CARE MANUAL RESUSCITATOR, CAT#VR-1000
FDA 510(k)
FDA Class 2
·Anesthesiology
cobas liat SARS-CoV-2 v2 nucleic acid test
FDA 510(k)
FDA Class 2
·Microbiology
M.I.S. TROCAR-CANNULA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SIMED S-100 PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular