Sterilizer, Soft-Lens, Thermal, Ac-Powered

FDA Pre-Market Approval

FDA Class 2 ·SOFT MATE(R) DW (HEFILICON A) CONTACT LENS

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE(R)PSA, IMMULITE(R) THIRD GENERATION PSA, IMMULITE(R) 2000

MODIFIED MYOCARDIAL TEMPERATURE SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 1000 ELECTRONIC CLINICAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFIED AIRWAY TEMPERATURE SENSOR

FDA 510(k)

FDA Class 2 ·General Hospital

Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFIED THERMAL WELL TEMPERATURE SENSOR

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR

FDA 510(k)

FDA Class 2 ·General Hospital

MON-A-THERM'S SKIN TEMPERATURE SENSOR

FDA 510(k)

FDA Class 2 ·General Hospital

TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS

FDA 510(k)

FDA Class 2 ·Dental

Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow

FDA 510(k)

FDA Class 2 ·Dental

ri-former Predictive Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ARTIGLASS L. O.R. GLASS SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN

FDA 510(k)

FDA Class 2 ·Immunology

ELECYS IGE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE TOTAL IGE

FDA 510(k)

FDA Class 2 ·Immunology

PHARMACIA IGE EIA

FDA 510(k)

FDA Class 2 ·Immunology