Cereve Sleep System

FDA 510(k)

FDA Class 2 ·Neurology

DECAPINOL ORAL RINSE

FDA 510(k)

FDA Class 2 ·Dental

Tangible Boost

FDA 510(k)

FDA Class 2 ·Ophthalmic

Valeda Light Delivery System

FDA 510(k)

FDA Class 2 ·Ophthalmic

“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”

FDA 510(k)

FDA Class 2 ·Pathology

GI Genius

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEUROSTAR TMS SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

KidneyIntelX.dkd

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NP Screen

FDA 510(k)

FDA Class 2 ·Microbiology

Medline ART Skin Harvesting System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Oxehealth Vital Signs

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTROL CF PANEL I CONTROL

FDA 510(k)

FDA Class 2 ·Microbiology

eXciteOSA with remote and eXciteOSA without remote

FDA 510(k)

FDA Class 2 ·Dental

XPERT MTB/RIF ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

Ruthless Spine RJB

FDA 510(k)

FDA Class 2 ·Orthopedic

SEEKER System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Magnetic Surgical System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE

FDA 510(k)

FDA Class 2 ·Cardiovascular

InSpace Subacromial Tissue Spacer System

FDA 510(k)

FDA Class 2 ·Orthopedic

Cognoa ASD Diagnosis Aid

FDA 510(k)

FDA Class 2 ·Neurology