SonoSite M-Turbo

FDA UDI

FUJIFILM SONOSITE, INC.·00841517100032·Diagnostic ultrasound system

FDA Pre-Market Approval

INDIRECT FLUORESCENT-ANTIBODY TEST FOR GONORRHEA (IFA-GC)

ABBOTT AXSYM HOMOCYSTEINE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ABBOTT IMX GLYCATED HEMOGLOBIN II

FDA 510(k)

FDA Class 2 ·Hematology

PHYSIOTHERAPY EQUIPMENT

Device

EU MDR · Eu Md Class 1 ·Total Gym Commercial LLC·On the market

DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM

FDA 510(k)

FDA Class 2 ·Immunology

PT-MULTI-CALIBRATOR, MODEL OPAT07

FDA 510(k)

FDA Class 2 ·Hematology

POWERED WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

ORTHOFAB WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

ORTHOFAB WHEELCHAIR ULTIMA (RIGID FRAME MANUAL WHEELCHAIR)

FDA 510(k)

FDA Class 1 ·Physical Medicine

ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR)

FDA 510(k)

FDA Class 1 ·Physical Medicine

Miracle Mix

FDA registration

GC CORPORATION-FUJI OYAMA FACTORY·1 product·🇯🇵 Japan

EPITEX FINISHING

FDA registration

GC ASAHI CORPORATION·1 product·🇯🇵 Japan