Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER M1000 SYSTEM

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·ORTHOSET BONE CEMENT

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

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

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Alinity m HCV

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·INDERMIL TISSUE ADHESIVE

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·OSTEOPAL

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys Anti-HCV Immunoassay

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Alinity m HCV

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Suture, Nonabsorbable, Synthetic, Polypropylene

FDA Pre-Market Approval

FDA Class 2 ·GORE-TEX SUTURE WITH PLEDGETS

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP / COBAS TAQMAN HCV TEST

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

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