BIOFEEDBACK TMG1, 4, BIO1, PA1, 2, BA1/BA30

FDA 510(k)

FDA Class 2 ·Neurology

BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI.

FDA 510(k)

FDA Class 2 ·Neurology

BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV

FDA 510(k)

FDA Class 2 ·Neurology

BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BAR

FDA 510(k)

FDA Class 2 ·Neurology

BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC1

FDA 510(k)

FDA Class 2 ·Neurology

BIOFEEDBACK DEVICE TG3, TG4

FDA 510(k)

FDA Class 2 ·Neurology

Diazyme PLAC® Test for Lp-PLA2 Activity

FDA 510(k)

FDA Class 2 ·Immunology

Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Powered wheelchair (mobility robot) (M4, M4U)

FDA 510(k)

FDA Class 2 ·Physical Medicine

DR VISION NEO, DR VISION DOU

FDA 510(k)

FDA Class 2 ·Radiology

40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICRO MODE-TRANS ELECTRICAL NEURAL STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

PROSAFE SAFETY SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

Topwide Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PREMIER-CRYPTOCOCCAL ANTIGEN

FDA 510(k)

FDA Class 2 ·Microbiology

ALPHA CRYPTOCOCCAL ANTIGEN EIA

FDA 510(k)

FDA Class 2 ·Microbiology

Dental Barrier and Sleeves

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm

FDA 510(k)

FDA Class 2 ·Anesthesiology

Digital Blood Pressure Monitor (Arm Type)

FDA 510(k)

FDA Class 2 ·Cardiovascular

GEMENI IGM ASSAY

FDA 510(k)

FDA Class 2 ·Immunology