OXYGEN MEDICELS, CITICELS

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA & TANDEM-E PSA IMMUNOENZYMETRIC ASSAY

PATHWAY ACCESS SHEATH CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PATHWAY ACCESS SHEATH CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KOBRA GPS FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLEARFLASH AC2100 COSMETIC SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE/IMMULITE 1000 PSA & 1000 THIRD GENERATION PSA

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

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

FDA Pre-Market Approval

FDA Class 2 ·IMMULITE 2500 PSA, IMMULITE 2500 THIRD GENERATION PSA

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM TOTAL PSA

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

FDA Pre-Market Approval

FDA Class 2 ·ELSECSYS FREE PSA IMMUNOASSAY,FREE PSA CALSET,FREE PSA CALCHECK

DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D

FDA 510(k)

FDA Class 2 ·Ophthalmic

SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

NOVEL PRINT CYAN ALGINATES

FDA 510(k)

FDA Class 2 ·Dental

ID MILLENNIUM, ID MOMENTS SILICONE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FEMMYCYCLE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology