133 results · 23ms · Sources: EU EUDAMED, US FDA

ARK Fentanyl II Assay

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE

FDA 510(k)
FDA Class 2 ·General Hospital

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

NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03

FDA 510(k)
FDA Class 2 ·Neurology

SKIN CARE LIGHT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

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

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

HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

TENS

FDA 510(k)
FDA Class 2 ·Neurology

TEETH IN AN HOUR - ARK IMPLANT CONCEPT

FDA 510(k)
FDA Class 2 ·Dental

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

FDA 510(k)
FDA Class 2 ·Physical Medicine

LOS 3D VISION 100

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology