ELITE SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

AFB (ABSORBABLE FOAM BUTTRESS)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SFB & CFB IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

BLASTOMYCES/ANTIGEN FOR IMMUNODIFUSION

FDA 510(k)

FDA Class 2 ·Microbiology

IMMUNODIFFUSSION REAGENTS/SEROLOGICAL

FDA 510(k)

FDA Class 2 ·Microbiology

BLASTOMYCES DERMATITIDIS, ANTIGEN

FDA 510(k)

FDA Class 2 ·Microbiology

LAPARETTE, MODEL LAP J L S H N

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

XTRACTOR, MODEL M143

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SFB AND CFB IMPLANTS - 5.0 PLATFORM

FDA 510(k)

FDA Class 2 ·Dental

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43R HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·V-X (POLYMACON) ASPHERIC SOFT(HYDROPHILIC) LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

Infrared Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503

FDA 510(k)

FDA Class 2 ·General Hospital

MFM-CMS CENTRAL MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELECTROCARDIOGRAPH

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology