FMX314 Surgical Platform

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

Belun Ring BLR-200 (BLR-200)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tyece OTC TENS Device

FDA 510(k)

FDA Class 2 ·Neurology

BLOOD PRESSURE METER MODEL NO. BPM888

FDA 510(k)

FDA Class 2 ·Cardiovascular

BRINDLEY & SMITH ET-1000

FDA 510(k)

FDA Class 2 ·Neurology

HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

FORTEC MI-150 DIGITAL BLOOD PRESSURE METER

FDA 510(k)

FDA Class 2 ·Cardiovascular

FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER

FDA 510(k)

FDA Class 2 ·Cardiovascular

FDTENS 2010

FDA 510(k)

FDA Class 2 ·Neurology

HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES

FDA 510(k)

FDA Class 2 ·General Hospital

PanopticAI Vital Signs

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANDORATE® Suction Valve and ANDORATE® Biopsy Valve

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FORTEC MI-305 & 306 DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

SURGICAL FACE MASKS PLUS ANTI-FOG SHIELD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Tyece OTC EMS System

FDA 510(k)

FDA Class 2 ·Physical Medicine

AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406

FDA 510(k)

FDA Class 2 ·Neurology

SMOKE EVACUATION ATTACHEMENT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery