23 results · 10ms · Sources: EU EUDAMED, US FDA

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Manometer, Blood-Pressure, Venous

FDA classification
FDA Class 2 ·Manometer, Blood-Pressure, Venous

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

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

ARK Fentanyl Assay

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

BRK TRANSSEPTAL NEEDLE

FDA 510(k)
FDA Class 2 ·Cardiovascular

NICOLET ARK SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

ARK Tramadol Assay

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ARK Hydrocodone Assay

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

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

Reprocessed BRK Transseptal Needle

FDA 510(k)
FDA Class 2 ·Cardiovascular

ARK Fentanyl II Assay

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ARK Levetiracetam II Assay

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

AQUA ARK, IMMERSION HYDROBATH

FDA 510(k)
FDA Class 2 ·Physical Medicine

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

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

CRK CONDYLAR RESURFACING TOTAL KNEE

FDA 510(k)
FDA Class 2 ·Orthopedic

ARK CARE DIABETES MANAGMENT SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ARK Voriconazole II Assay Test System

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL

FDA 510(k)
FDA Class 2 ·Clinical Toxicology