PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TL 20W/12/RS & TL 40W/12/RS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CLEO TL80W PROFESSIONAL CLEO TL80W PROFESSIONAL R, CLEO TL100 W PROFESSIONAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE

FDA 510(k)

FDA Class 2 ·Anesthesiology

2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES

FDA 510(k)

FDA Class 2 ·Orthopedic

EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUTE COUNT TUBES

FDA 510(k)

FDA Class 2 ·Hematology

12-LEAD GLOVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIAC COMPUTATION SOFTWARE PACKAGE

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES

FDA 510(k)

FDA Class 2 ·Hematology

VOLUME COMPUTATION SOFTWARE PACKAGE

FDA 510(k)

FDA Class 2 ·Cardiovascular

3.7MM/5.0MM DYNAMIC LOCKING SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

TAS-211/2.3 ULTRATHIN FLEXIBLE ENDOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology