MERCURY CPAP

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Aesculap OrthoPilot Next Generation

FDA 510(k)

FDA Class 2 ·Neurology

Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300

FDA 510(k)

FDA Class 2 ·Neurology

V-PATCH SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Infinix INFX-8000V, V6.40

FDA 510(k)

FDA Class 2 ·Radiology

APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System

FDA 510(k)

FDA Class 2 ·Radiology

CLEARFIL POSTERIOR 3

FDA 510(k)

FDA Class 2 ·Dental

Cartesion Prime (PCD-1000A/3) V10.15

FDA 510(k)

FDA Class 2 ·Radiology

INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V

FDA 510(k)

FDA Class 2 ·Radiology

FNL-10P, FIBER NASOPARHYNGOSCOPE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

FENESTRATED INFUSION CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

ENNOVATE Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

RemunityPRO™ Pump for Remodulin® (treprostinil) Injection

FDA 510(k)

FDA Class 2 ·General Hospital

HAEMOBAND MULTI-LIGATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cartesion Prime, PCD-1000A, V10.7

FDA 510(k)

FDA Class 2 ·Radiology

ONTEX AND OTHERS PROPRIETARY NAMES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology