10,000 results
·
103ms
·
Sources: EU EUDAMED, US FDA
QUART ARTERIAL FILTER, MODEL HBF 140
FDA 510(k)
FDA Class 2
·Cardiovascular
DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PLATO 3300/1300
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HERPTRAN CONCENTRATE
FDA 510(k)
FDA Class 2
·Microbiology
BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2
FDA 510(k)
FDA Class 2
·Hematology
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Immunology
DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
THYROID CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACA VANCOMYCIN CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Toxicology
308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
FDA 510(k)
FDA Class 2
·Hematology
Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CRONEX RADIATION THERAPY CASSETTE
FDA 510(k)
FDA Class 2
·Radiology
Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2
FDA 510(k)
FDA Class 2
·Hematology
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CAPOGEN Laser Cap
FDA 510(k)
FDA Class 2
·Physical Medicine
MODIFICATION OF N/T PROTEIN CONTROL SL
FDA 510(k)
FDA Class 1
·Clinical Chemistry