KEGEL SMART, KEGELSMART PEARL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Vital Navigation System

FDA 510(k)

FDA Class 2 ·Neurology

ACCI-GUARD REUSABLE HOLDER

FDA 510(k)

FDA Class 2 ·General Hospital

FORCE GSU SYSTEM W/ LAPAROSCOPIC OPTION

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ELASTIC IMPRESSION CREAM

FDA 510(k)

FDA Class 2 ·Dental

MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEV-10 NEGATIVE PRESSURE VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Surefire Precision Infusion System

FDA 510(k)

FDA Class 2 ·Cardiovascular

TightRail Guardian Motorized Dilator Sheath

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMOOTHCOOL HR SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Grappler Suture Anchor System

FDA 510(k)

FDA Class 2 ·Orthopedic

POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS)

FDA 510(k)

FDA Class 2 ·Ophthalmic

E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD AND ELECTROSURGICAL PATIENT RETURN ELECTRODE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMAGER

FDA 510(k)

FDA Class 2 ·Radiology

ORIGINS LIPOHARVESTING SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Polaris Spinal Growth System

FDA 510(k)

FDA Class 2 ·Orthopedic

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUANTUM LIGHT THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine