COULTER LH 750 BODY FLUIDS APPLICATION

FDA 510(k)

FDA Class 2 ·Hematology

NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON

FDA 510(k)

FDA Class 1 ·Ophthalmic

MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC

FDA 510(k)

FDA Unclassified ·Unknown

FLOWCARE TLG REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

CLO-SURPLUSP.A.D.

FDA 510(k)

FDA Unclassified ·Unknown

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

Unicel DxH 800 Coulter Cellular Analysis System

FDA 510(k)

FDA Class 2 ·Hematology

Reprocessed ArthoCare Ablation Wand

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Livewire Electrophysiology Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

LAA Exclusion System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DynaCAD

FDA 510(k)

FDA Class 2 ·Radiology

HAEMOPHILUS TEST MEDIUM AGAR (HTM)

FDA 510(k)

FDA Class 2 ·Microbiology

UroNav System

FDA 510(k)

FDA Class 2 ·Radiology