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

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

gentleheel® Adult Incision Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ComfortGuard Surgical Isolation Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LapBox Tissue Containment Removal System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff

FDA 510(k)

FDA Class 2 ·Cardiovascular

MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)

FDA 510(k)

FDA Class 2 ·Physical Medicine

DEXON DISSECTING SPONGE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TEETH IN AN HOUR - ARK IMPLANT CONCEPT

FDA 510(k)

FDA Class 2 ·Dental

BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208

FDA 510(k)

FDA Class 2 ·Cardiovascular

GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GRI-Alleset Veress Needle

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery