DURAPHAT

FDA 510(k)

FDA Class 2 ·Dental

HEMOGLOBIN ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)

FDA 510(k)

FDA Class 2 ·Hematology

FOCUS-GHB

FDA 510(k)

FDA Class 2 ·Hematology

FIBEROPTIC CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROTARY* POWERED SCALPEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LYHER® Oral fluid Multi-Drug Test Kit (Cube)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PowerDot PD-01MT2 Muscle Stimulator

FDA 510(k)

FDA Class 2 ·Physical Medicine

PowerDot PD-01MT2 Muscle Stimulator

FDA 510(k)

FDA Class 2 ·Physical Medicine

PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)

FDA 510(k)

FDA Class 2 ·Physical Medicine

PowerDot PD-01M

FDA 510(k)

FDA Class 2 ·Physical Medicine

PowerDot PD-01MT

FDA 510(k)

FDA Class 2 ·Physical Medicine

Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PHADEBACT MONOCLONAL GC TEST, MODIFICATION

FDA 510(k)

FDA Class 2 ·Microbiology

MONO-LATEX (TM) SLIDE TEST

FDA 510(k)

FDA Class 2 ·Immunology

Lifetech Cardio Model 8301 Temporary Pacemaker

FDA 510(k)

FDA Class 2 ·Cardiovascular

Diode laser Treatment System (K18)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital