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

ARK Care®

FDA UDI

ARKRAY USA, INC.·00015482000011·ARK Care is a Diabetes Management System that i...

BRK-1™

FDA UDI

ST. JUDE MEDICAL CARDIOVASCULAR DIVISION·05414734207232·XS Transseptal Needle

BRK-1™

FDA UDI

ST. JUDE MEDICAL CARDIOVASCULAR DIVISION·05414734207225·Transseptal Needle

BRK-1™

FDA UDI

ST. JUDE MEDICAL CARDIOVASCULAR DIVISION·05414734205184·XS Transseptal Needle

BRK-1™

FDA UDI

ST. JUDE MEDICAL CARDIOVASCULAR DIVISION·05414734205177·Transseptal Needle

BRK-1™

FDA UDI

ST. JUDE MEDICAL CARDIOVASCULAR DIVISION·05414734205191·XS Transseptal Needle

BRK-1™

FDA UDI

ST. JUDE MEDICAL CARDIOVASCULAR DIVISION·05414734205160·Transseptal Needle

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 Methotrexate II Assay

FDA 510(k)

FDA Unclassified ·Unknown

BRAINTRACE

FDA 510(k)

FDA Class 2 ·Neurology

MiNi Internal Implant System

FDA 510(k)

FDA Class 2 ·Dental

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

Campus PHYSIO Relax Gr.0

Device

EU MDR · Eu Md Class 1 ·Berollka-aktiv Rollstuhltechnik GmbH·On the market

AUTO REF/KERATOMETER ARK-1e

Device

EU MDR · Eu Md Class 2a ·NIDEK.CO.Ltd.,·On the market·32 countries