BeautiLink SA

FDA 510(k)

FDA Class 2 ·Dental

SGARLATO FLEXIBLE HINGE TOE IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

2 CM PERIPHERAL CUTTING BALOON

FDA 510(k)

FDA Class 2 ·Cardiovascular

CephSimulation

FDA 510(k)

FDA Class 2 ·Radiology

QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PIVO

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STGC

FDA 510(k)

FDA Class 2 ·Orthopedic

Veloxion System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

iFuse Implant System(R)

FDA 510(k)

FDA Class 2 ·Orthopedic

COIL AND COIL DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

LQUET CANNULA/TROCAR SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY

FDA 510(k)

FDA Class 2 ·Orthopedic

PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

INFRASONICS VENTILATOR ADULT STAR, MODIFICATION

FDA 510(k)

FDA Class 2 ·Anesthesiology

Vector Hammertoe Correction System

FDA 510(k)

FDA Class 2 ·Orthopedic

Dermal Cooling System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

InPen Dose Calculator

FDA 510(k)

FDA Class 2 ·Anesthesiology

COROENT XL-F SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152

FDA 510(k)

FDA Class 2 ·Clinical Toxicology