Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·PRONOVA ABSORABLE SUTURE, USP

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·BELOS VR-T ICD

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·BAUSCH AND LOMB HEFILCON A, B AND C HYDROPHILIC CONTACT LENSES

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE-EASE TM 2501

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM ANTIBODY TO HCV (ANTI-HCV)

Self-Contained Blood Grouping

FDA classification

FDA Class 2 ·Self-Contained Blood Grouping

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED REBEL PTCA CATHETER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AXSYM ANTI-HCV

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROCROSS(TM) OVER-THE-WIRE BALLOON DILATION WITH RELY(TM) BALLOON MATERIAL AND HYDRO/PEL(R) COATING

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

FDA Pre-Market Approval

FDA Class 2 ·S-ROM POLY-DIAL CONSTRAINED LINER

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·IMX TACROLIMUS II

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·LITHOSTAR

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS(R) PINKERTON .018(TM) CORONARY DILATION CATHETER

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER