Elecsys Folate III

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Medline Integrated Arterial Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Spine Wave Navigated Instruments

FDA 510(k)

FDA Class 2 ·Neurology

TempSure System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

Doppler FHR Detector (BF-500D+, BF-560)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

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

A5 Anesthesia System

FDA 510(k)

FDA Class 2 ·Anesthesiology

Bashir Plus Endovascular Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Salvo® Spine System

FDA 510(k)

FDA Class 2 ·Orthopedic