ExsoMed ITN Cannulated Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Monarch eTNS System

FDA 510(k)

FDA Class 2 ·Neurology

KINAMED CTN STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ICAN GT DRAINAGE BAG

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ICAN NEEDLE COUNTERS

FDA 510(k)

FDA Class 2 ·General Hospital

(SPAG) MODEL SPAG-2 6000 SERIES

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE

FDA 510(k)

FDA Class 2 ·Anesthesiology

WATER COLUMN RELIEF VALVE

FDA 510(k)

FDA Class 2 ·Anesthesiology

CT/N-II SCANNER SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ACR LAB Urine Analysis Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OPUS TROPONIN I (CTN) TEST MODULES

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TITANIUM CANNULATED TIBIAL NAIL (TI CTN)

FDA 510(k)

FDA Class 2 ·Orthopedic

Rotium Bioresorbable Wick

FDA 510(k)

FDA Class 2 ·Orthopedic

Octane Mechanical Thrombectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MSAS-VANTAGE

FDA 510(k)

FDA Class 2 ·Neurology

ACCRAASSAY RID KITS

FDA 510(k)

FDA Class 2 ·Immunology

MSAS PROFESSIONAL

FDA 510(k)

FDA Class 2 ·Neurology

CARD GUARD, MODEL CG-2000

FDA 510(k)

FDA Class 2 ·Cardiovascular

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®

FDA 510(k)

FDA Class 2 ·Neurology