EMPHASYS Acetabular System

FDA 510(k)

FDA Class 2 ·Orthopedic

K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER

FDA 510(k)

FDA Class 2 ·Anesthesiology

SYMPHONY GLUCOSE MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD PhaSeal Optima Closed System Transfer Device

FDA 510(k)

FDA Class 2 ·General Hospital

ORTHADAPT PR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Salvo™ Spine System

FDA 510(k)

FDA Class 2 ·Orthopedic

Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile

FDA 510(k)

FDA Class 2 ·Cardiovascular

SENORX ES-300

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VISUAL-ICE CRYOABLATION SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENSPLINT TM BONE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Universal Light Handle Cover, Light Handle Cover

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

Revolution Full Face Mask

FDA 510(k)

FDA Class 2 ·Anesthesiology

PICASSO/ PICASSO LITE/ PICASSO PERIO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ITI STENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology