FIDIS CONNECTIVE 8

FDA 510(k)

FDA Class 2 ·Immunology

FIDIS TM THYRO, MODEL MX002

FDA 510(k)

FDA Class 2 ·Immunology

Aniti-Snore Mouthguard+

FDA 510(k)

FDA Class 2 ·Dental

FIDIS VASCULITIS, MODEL MX007

FDA 510(k)

FDA Class 2 ·Immunology

FIDIS CELIAC

FDA 510(k)

FDA Class 2 ·Immunology

FIDIS DSDNA

FDA 510(k)

FDA Class 2 ·Immunology

FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006

FDA 510(k)

FDA Class 2 ·Immunology

FIDIS CONNECTIVE 10, MODEL MX006

FDA 510(k)

FDA Class 2 ·Immunology

FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO FIDIS VASCULITIS, MODEL MX007

FDA 510(k)

FDA Class 2 ·Immunology

TRI-BALL

FDA 510(k)

FDA Class 2 ·Anesthesiology

DOSI FLOW

FDA 510(k)

FDA Class 2 ·General Hospital

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170

Complement C9, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Complement C9, Antigen, Antiserum, Control

Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control

FDA classification

FDA Class 2 ·Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ST AIA-PACK PA

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER