CARPAL ENGAGING WRIST FUSION PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

HEMODIALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Changer, Tube, Endotracheal

FDA Pre-Market Approval

FDA Class 2 ·ENDOTRACHEAL TUBE CHANGERS

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK Fentanyl Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NICOLET ARK SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

BRK TRANSSEPTAL NEEDLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARK Tramadol Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK Hydrocodone Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK EDDP Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK Lacosamide Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LapBox Power Tissue Containment System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AQUA ARK, IMMERSION HYDROBATH

FDA 510(k)

FDA Class 2 ·Physical Medicine

Reprocessed BRK Transseptal Needle

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARK Levetiracetam II Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK Fentanyl II Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Ulthera® System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery