breastscape v1.0

FDA 510(k)

FDA Class 2 ·Radiology

DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600

FDA 510(k)

FDA Class 2 ·Immunology

Cefaly

FDA 510(k)

FDA Class 2 ·Neurology

Functional MR V1.0

FDA 510(k)

FDA Class 2 ·Radiology

Implantswiss Dental Implant System, Implantswiss Dental Abutment System

FDA 510(k)

FDA Class 2 ·Dental

MR Diffusion Perfusion Mismatch V1.0

FDA 510(k)

FDA Class 2 ·Radiology

CT Perfusion V1.0

FDA 510(k)

FDA Class 2 ·Radiology

MR DWI/FLAIR Measurement V1.0

FDA 510(k)

FDA Class 2 ·Radiology

STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Olea S.I.A. Neurovascular V1.0

FDA 510(k)

FDA Class 2 ·Radiology

Olea Sphere V3.0

FDA 510(k)

FDA Class 2 ·Radiology

THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK

FDA 510(k)

FDA Class 2 ·Immunology

Implantswiss Dental Implant System and Implantswiss Dental Abutment System

FDA 510(k)

FDA Class 2 ·Dental

CINA

FDA 510(k)

FDA Class 2 ·Radiology

RESPISENS

FDA 510(k)

FDA Class 2 ·Radiology