Alpha Pure

FDA 510(k)

FDA Class 2 ·Dental

VECTRA LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MICT TSH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AIA-PACK BRCA, ST AIA PACK BRCA

FDA 510(k)

FDA Class 2 ·Immunology

VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AcQMap High Resolution Imaging and Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

GENOX MODEL CT-1

FDA 510(k)

FDA Class 2 ·Anesthesiology

OPUS SPEEDSTITCH SUTURE DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACUSON ACUNAV 8F ULTRASOUND CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELECTROTRACE, MODIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTERSEPT* OXYGEN GAS LINE FILTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMPHETAMINES EIA ASSAY MODIFICATION

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

IDR

FDA 510(k)

FDA Class 2 ·Radiology

TRIA HAIR REMOVAL LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Physio Flex Annuloplasty Ring

FDA 510(k)

FDA Class 2 ·Cardiovascular

RPM RESPIRATORY GATING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

COMEN MULTI-PARAMETER PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

PREGNAGEN 1-STEP PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OMNILINK .018 BILIARY STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology