CEP 8 SPECTRUMORANGE DNA PROBE KIT

FDA 510(k)

FDA Class 2 ·Immunology

Xpert VanA Assay

FDA 510(k)

FDA Class 2 ·Microbiology

VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT

FDA 510(k)

FDA Class 2 ·Immunology

CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE

FDA 510(k)

FDA Class 2 ·Immunology

UROVYSION BLADDER CANCER RECURRENCE KIT

FDA 510(k)

FDA Class 2 ·Immunology

XPERT FLU

FDA 510(k)

FDA Class 2 ·Microbiology

XPERT MRSA/SA BLOOD CULTURE ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

XPERT CT/NG

FDA 510(k)

FDA Class 2 ·Microbiology

ANEUVYSION MULITICOLOR DNA PROBE KIT

FDA 510(k)

FDA Class 2 ·Immunology

XPERT HEMOSIL FACTOR II & FACTOR V ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DYNA IMPLANT DESIGN

FDA 510(k)

FDA Class 2 ·Dental

XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10

FDA 510(k)

FDA Class 2 ·Microbiology

XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065

FDA 510(k)

FDA Class 2 ·Microbiology

COM-TENS: A NEUROSTIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

Precision GI

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Injector, Pen

FDA classification

FDA Class 2 ·Injector, Pen

Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief

FDA classification

FDA Class 2 ·Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief

AIXPLORER

FDA 510(k)

FDA Class 2 ·Radiology

Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems

FDA 510(k)

FDA Class 2 ·Radiology