SOLO ORTHO

FDA 510(k)

FDA Class 2 ·Dental

RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

HALO360' COAGULATION CATHETER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DX1-PORTABLE

FDA 510(k)

FDA Class 2 ·Anesthesiology

DUAL LUMEN EMBOLECTOMY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

RESPIRTECHPRO

FDA 510(k)

FDA Class 2 ·Anesthesiology

BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT

FDA 510(k)

FDA Class 2 ·Immunology

BIRD V.I.P. GOLD/STERLING

FDA 510(k)

FDA Class 2 ·Anesthesiology

SONOS AIRES 600 (SA-600)

FDA 510(k)

FDA Class 2 ·Radiology

SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GENESIS II

FDA 510(k)

FDA Class 2 ·Radiology

YESNG REUSABLE ELECTROSURGICAL ELECTRODE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LASER INDIRECT OPHTHALMOSCOPE (LIO)

FDA 510(k)

FDA Class 2 ·Ophthalmic

SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MYOSCIENCE CRYO-TOUCH

FDA 510(k)

FDA Class 2 ·Neurology

MARX PLAN, RADIATION THERAPY TREATMENT PLAN SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CEDIA (TM) CORTISOL ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ProBeam 360° Proton Therapy System v2.0 (Multiroom)

FDA 510(k)

FDA Class 2 ·Radiology

TUBING CONNECTORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology