BAYER PSA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ACTIVE PSA ELISA (DSL-10-9700)

FDA 510(k)

FDA Class 2 ·Immunology

THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

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

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM

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

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS

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

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS TOTAL PSA IMMUNOASSAY/TOTAL PSA CALSET

HAIRMAX DUAL 12

FDA 510(k)

FDA Class 2 ·Physical Medicine

CARETONE II

FDA 510(k)

FDA Class 2 ·Cardiovascular

S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)

FDA 510(k)

FDA Class 2 ·Orthopedic

TANTHERA-T35

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ANATOMICAL MALAR IMPLANT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MAGNETOM Vida

FDA 510(k)

FDA Class 2 ·Radiology

ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400

FDA 510(k)

FDA Class 2 ·General Hospital

DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INTRAORAL MANDIBULAR DISTRACTION DEVICE

FDA 510(k)

FDA Class 2 ·Dental

N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRONOSCO X-POSURE SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL

FDA 510(k)

FDA Class 2 ·Radiology