Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK OTW (OVER-THE-WIRE) AND QUANTUM MAVERICK OTW

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·TELESCOPE PTCA BALLOON CATHETER

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·LT-CAGE LUMBAR TAPERED FUSION DEVICE

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys Anti-HCV Immunoassay

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·MEDSTONE STS-T LITHOTRIPTER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI APOLLO RELY SP OVER-THE-WIRE BALLOON DILATATION CATHETER WITH HYDRO/PEL COATING AND MINIQUET DEVICE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY FUSION THREADED CAGE (TFC) DEVICE

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·ENDURANCE BONE CEMENT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·BOSTON SCIENTIFIC QUANTUM MAVERICK PTCA DILATATION CATHETERS

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP / COBAS TAQMAN CMV TEST

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·FISCHER IMAGING CORPORATION SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ORACLE MEGASONICS FIVE-64 PTCA CATHETER

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX TACROLIMUS II

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys Anbti-HCV Immunoassay

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·TRANSPORTABLE MODEL STS-T LITHOTRIPTER

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·MAMMOGRAPHY CAD ENGINE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

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

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA DILATATION CATHETERS FOR VALOR AND VALOR XL PTCA