1,633 results · 29ms · Sources: EU EUDAMED, US FDA

Plaxpot Multi Plasma

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Focus Cap

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ASSERACHROM PF4 KIT

FDA 510(k)
FDA Class 2 ·Hematology

LAPARETTE, MODEL LAP J L S H N

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

XTRACTOR, MODEL M143

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL

FDA 510(k)
FDA Class 2 ·Immunology

BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2

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

BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2

FDA 510(k)
FDA Class 2 ·Hematology

Dimension Vista MMB Assay

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454

FDA 510(k)
FDA Class 2 ·Immunology

ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

INNOVANCE D-DIMER, MODEL OPBP09

FDA 510(k)
FDA Class 2 ·Hematology

LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIMENSION VISA ENZ 2 CAL

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56

FDA 510(k)
FDA Class 2 ·Clinical Chemistry