Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SYNSOFT(TM) (POLYMACON) BIFOCAL CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·PARAPERM O2 CLEAR & BLUE LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·(POLYMACON) SOF-FORM II CONTACT LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CELUSOFT (POLYMACON) LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·(POLYMACON) SOF-FORM II CONTACT LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SYNSOFT(TM) (POLYMACON) BIFOCAL CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOF-FORM ALLVUE MULTIFOCAL (POLYMACON) CONTACT LEN

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·(POLYMACON) CONTACT LENSES

Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARE SU01A SUCTION ASPIRATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GYRUS ENDOUROLOGY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GYRUS HYSTEROSCOPIC RESECTOSCOPE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PLASMAKINETIC ENDOUROLOGY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PLASMAKINETIC GENERATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BABY DOPPLEX 4000 (BD4000)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SIMPLA S4, S5, S7

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology