CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000

FDA 510(k)

FDA Class 2 ·Cardiovascular

dS Sentinelle Breast 16ch 3.0T Coil

FDA 510(k)

FDA Class 2 ·Radiology

SleepTight Mouthpiece STZ

FDA 510(k)

FDA Class 2 ·Dental

EN-SNARE ENDOVASCULAR SNARE AND CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

COULTER LH 750 HEMATOLOGY ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

Luminice

FDA 510(k)

FDA Class 2 ·Neurology

MUCHECK V7.0

FDA 510(k)

FDA Class 2 ·Radiology

AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS

FDA 510(k)

FDA Class 2 ·Hematology

MULTIDIRECTIONAL THREADED PEG

FDA 510(k)

FDA Class 2 ·Orthopedic

LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES

FDA 510(k)

FDA Class 2 ·Neurology

8ch Wrist Coil

FDA 510(k)

FDA Class 2 ·Radiology

COULTER LH 750 BODY FLUIDS APPLICATION

FDA 510(k)

FDA Class 2 ·Hematology

FLOWCARE TLG REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

UroNav 4

FDA 510(k)

FDA Class 2 ·Radiology

SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MANAN TECHNA-CUT ASPIRATION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SHOULDER FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MRDx BCR-ABL Test, MRDx BCR-ABL Test Software

FDA 510(k)

FDA Class 2 ·Medical Genetics

Reprocessed Shavers/Burs

FDA 510(k)

FDA Class 2 ·Orthopedic

ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M

FDA 510(k)

FDA Class 2 ·Hematology