SpermAlign Sperm Separation Device

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HUMAN IGA CSF KIT FOR USE ON SPAPLUS

FDA 510(k)

FDA Class 2 ·Immunology

PICO 7 Single Use Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

804SIII; 804W; LIBRA TENS; 410; S-TENS II

FDA 510(k)

FDA Class 2 ·Neurology

SPINEANALYER MODEL SAPOC

FDA 510(k)

FDA Class 2 ·Radiology

Béa Applicator (BAP-GB-01)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Neurosign V4 Intraoperative Nerve Monitor

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MOTION WATCH AND PRO-DIARY

FDA 510(k)

FDA Class 2 ·Neurology

GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Quantum Ventilation Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

25-Hydroxy Vitamin Ds EIA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Altomed Malhotra Platinum Segments

FDA 510(k)

FDA Class 2 ·Ophthalmic

PASR/QUIETNITE

FDA 510(k)

FDA Class 2 ·Dental

Liquid CO2-2 (LCO2-2)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BraveCX

FDA 510(k)

FDA Class 2 ·Radiology

SURGIDEK S

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Brainomix 360 e-ASPECTS

FDA 510(k)

FDA Class 2 ·Radiology

Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)

FDA 510(k)

FDA Class 2 ·Neurology

Rocket Indwelling Pleural Catheter (IPC) Insertion Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular