System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV ON COBAS E 411

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·cobas AmpliPrep/cobas TaqMan CMV Test

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AmpliPrep/COBAS TaqMan Cytomegalovirus Test

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R) PTCA CATHETER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV ON COBAS E 601

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·COBAS INTEGRA 400 PLUS CYCLOSPORINE

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

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

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS TITAN & TITAL XL DILATION CATHETERS

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·UBIS 5000 BONE SONOMETER

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE

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

FDA Pre-Market Approval

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

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·KAINOX RV-S/ KAINOX VCS ICD LEADS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·CONTACLAIR MULTI-PURPOSE SOLUTION

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II TEST SYSTEM

Light, Lymphedema Reduction, Low Energy

FDA classification

FDA Class 2 ·Light, Lymphedema Reduction, Low Energy