HARMONIE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

NOTTA AMBULATORY RECORDER

FDA 510(k)

FDA Class 2 ·Neurology

HARMONE-SCHWARZER EEG SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

STIMATE N601 TENS

FDA 510(k)

FDA Class 2 ·Neurology

Hi-Torque Command 18 Guide Wire

FDA 510(k)

FDA Class 2 ·Cardiovascular

Full Automatic(NIBP) Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aulisa Temperature Module (TM0002)

FDA 510(k)

FDA Class 2 ·General Hospital

DRX QT. HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GlucoLeader Enhance 2 Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TAKI DISPOSABLE ACUPUNCTURE NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

CW-DISPOSABLE ACUPUNCTURE NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

MiiS Horus Scope DPT 100

FDA 510(k)

FDA Class 2 ·Ophthalmic

DIGITAL EYE-FUNDUS CAMERA

FDA 510(k)

FDA Class 2 ·Ophthalmic

AcroDTI Visualizer

FDA 510(k)

FDA Class 2 ·Radiology

Armada 18 PTA Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADVIA Centaur Herpes-1 IgG

FDA 510(k)

FDA Class 2 ·Microbiology

Theranos Herpes Simplex Virus-1 IgG Assay

FDA 510(k)

FDA Class 2 ·Microbiology

LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG

FDA 510(k)

FDA Class 2 ·Microbiology