SKYLARK MODEL 1001 TENS DEVICE

FDA 510(k)

FDA Class 2 ·Neurology

RESOLVE BILIARY DRAINAGE CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H

FDA 510(k)

FDA Class 2 ·Cardiovascular

INFUSION CATHETER EXTENSION SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SIMPLYGO HANDS FREE BREAST PUMP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PINPOINT GT SAFETY INTRODUCER NEEDLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Merge PACS

FDA 510(k)

FDA Class 2 ·Radiology

SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF

FDA 510(k)

FDA Class 2 ·Anesthesiology

HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bashir Plus Endovascular Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Salvo® Spine System

FDA 510(k)

FDA Class 2 ·Orthopedic

CARTO XP EP NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Phoenix ICON, Phoenix ICON GO

FDA 510(k)

FDA Class 2 ·Ophthalmic

SURVEYOR CENTRAL STATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sera

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Cautery Tip Cleaner

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1

FDA 510(k)

FDA Class 2 ·General Hospital

Journey II Unicompartmental Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic