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

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA ON THE SYNCHRON LXI 725 SYSTEM

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

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E 170

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

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

Lens, Contact, (Disposable)

FDA classification

FDA Class 2 ·Lens, Contact, (Disposable)

Von Willebrand Factor Assay

FDA classification

FDA Class 2 ·Von Willebrand Factor Assay

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·cobas CMV Test for use on the cobas 6800/8800 System

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·cobas CMV test for use on the cobas 6800/8800 System

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS TaqMan HCV Test, v2.0 for use on the High Pure System

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601 AND COBAS E 602

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

DermaSensor

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GENEX BONE GRAFT SUBSTITUTE

FDA 510(k)

FDA Class 2 ·Orthopedic

Red Dot

FDA 510(k)

FDA Class 2 ·Radiology

ORTHOTRON MUSCLE STIMULATOR MK II DC

FDA 510(k)

FDA Class 2 ·Physical Medicine

GRAFTSITE

FDA 510(k)

FDA Class 2 ·Anesthesiology

STERILE STORM (R) OPERATING KIT

FDA 510(k)

FDA Class 2 ·Orthopedic