Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M1000 SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER M1000

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M5000D AND M5000DM, (SOFTWARE VERSION 5.2)

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·CHROMIC GUT SUTURE

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·KONTRON CUTANEOUS PCO2 MONITOR

Graft, Vascular, Synthetic/Biologic Composite

FDA Pre-Market Approval

FDA Class 2 ·ALBUMIN COATED DEBAKEY(R) VASCULAR(R) VASCULAR-II

Suture, Nonabsorbable, Synthetic, Polyamide

FDA Pre-Market Approval

FDA Class 2 ·NONABSORBABLE SURG. SUTURES, NYLON

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·KONTRON CUTANEOUS PCO2 MONITOR

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

FDA Pre-Market Approval

FDA Class 2 ·TOTAL PSA MICROTITER ELISA

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·CHROMIC GUT SUTURE

Suture, Nonabsorbable, Silk

FDA Pre-Market Approval

FDA Class 2 ·NONABSORBABLE SURG. SUTURES, BRAIDED SILK

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV ASSAY

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOSTON LENS(R) CLEANER

Suture, Nonabsorbable, Silk

FDA Pre-Market Approval

FDA Class 2 ·NONABSORBABLE SURG. SUTURES, BRAIDED SILK

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM