TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UGFT3; FHT7

FDA 510(k)

FDA Class 2 ·General Hospital

NON-INVASIVE INFRARED (NIR)

FDA 510(k)

FDA Class 2 ·General Hospital

Temple Touch Pro (TTP) Non-invasive temperature monitoring system

FDA 510(k)

FDA Class 2 ·General Hospital

SIRIO H3

FDA 510(k)

FDA Class 2 ·Radiology

ELITE SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER)

FDA 510(k)

FDA Class 2 ·Anesthesiology

GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRUCATH.IP

FDA 510(k)

FDA Class 2 ·Immunology

GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CARE SU01A SUCTION ASPIRATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

FDA 510(k)

FDA Class 2 ·Cardiovascular

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

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

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