Monarch eTNS System

FDA 510(k)

FDA Class 2 ·Neurology

B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HEARTFLOW FFRCT

FDA 510(k)

FDA Class 2 ·Cardiovascular

BEAR (Bridge-Enhanced ACL Repair) Implant

FDA 510(k)

FDA Class 2 ·Orthopedic

ToothWave™

FDA 510(k)

FDA Class 2 ·Dental

Q-Collar

FDA 510(k)

FDA Class 2 ·Neurology

CEDIA SIROLIMUS ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Luminopia One

FDA 510(k)

FDA Class 2 ·Ophthalmic

EarLens Contact Hearing Device

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MOERAE SURGICAL MARKING PEN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RELIZORB

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Medtronic DUET External Drainage and Monitoring System

FDA 510(k)

FDA Class 2 ·Neurology

Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

GIVEN DIAGNOSTIC IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

esolution

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMStent® Tracheobronchial Covered Stent System

FDA 510(k)

FDA Class 2 ·Anesthesiology

WIDEXLINK IN CLEAR SERIES HEARING AIDS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ipsogen JAK2 RGQ PCR Kit

FDA 510(k)

FDA Class 2 ·Medical Genetics

Viz HCM

FDA 510(k)

FDA Class 2 ·Cardiovascular

STRATIFY JCV(TM) ANTIBODY

FDA 510(k)

FDA Class 2 ·Microbiology