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

HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS

FDA 510(k)

FDA Class 2 ·General Hospital

DRE VENTURA

FDA 510(k)

FDA Class 2 ·Anesthesiology

ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LapBox Tissue Containment Removal System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ARK Voriconazole II Assay Test System

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARK CARE DIABETES MANAGMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CRK CONDYLAR RESURFACING TOTAL KNEE

FDA 510(k)

FDA Class 2 ·Orthopedic

ELECTRONIC CELL ENERGIZER

FDA 510(k)

FDA Class 2 ·Physical Medicine

Fiagon Navigation – PointerTube Straight and PointerTube Keat

FDA 510(k)

FDA Class 2 ·Neurology

icobrain

FDA 510(k)

FDA Class 2 ·Radiology