SPIRAL FLOW PERIPHERAL VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Endofresh Digestive Endoscopy System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Disposable Surgical Gowns

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Electric wheelchair (KR-8807)

FDA 510(k)

FDA Class 2 ·Physical Medicine

FLUORESCENT ANTI. ANTI-HUMAN C3

FDA 510(k)

FDA Class 2 ·Immunology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT ARCHITECT ANTI-HCV

QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA

FDA 510(k)

FDA Class 2 ·Immunology

PICA WHOLE-BODY MRI SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ANTI-KERATIN-HMW PRIMARY ANTI-BODY

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTI

FDA 510(k)

FDA Class 2 ·Immunology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-HA-IGMK PLUS

ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-RNP AND ANTI-SM ANTIBODY TEST

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-GM & ANTI-KM TYPING SERUMS

FDA 510(k)

FDA Class 2 ·Immunology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-AB-HAVK PLUS ASSAY

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Alinity i Anti-HCV Reagent Kit, Alinity i Anti-HCV Calibrator, Alinity i Anti-HCV Controls

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS

AxSOS 3Ti

FDA 510(k)

FDA Class 2 ·Orthopedic

ANTI-HAV

FDA 510(k)

FDA Class 2 ·Microbiology