COLORIMETRIC DETERMINATION (LDH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CARESIDE LDH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WAKO LDH CII TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

Assut Filbloc Permanent Sutures

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Filbloc

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPERMICIDAL LUBRICATED MALE LATEX CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Di (O-Hydroxyphenylimine) Ethane, Calcium

FDA classification

FDA Class 2 ·Di (O-Hydroxyphenylimine) Ethane, Calcium

Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

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

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)

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

FDA Pre-Market Approval

FDA Class 2 ·Dimension Vista TPSA Flex reagent cartridge (K6451)

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

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

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

FDA Pre-Market Approval

FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

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

FDA Pre-Market Approval

FDA Class 2 ·Dimension Vista TPSA Flex reagent cartridge

Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·COBAS INTEGRA 400 PLUS CYCLOSPORINE

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

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex Reagent Cartridge