CATHETER BALLOON DILATOR PRESSURE GAUGE

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRICON M TOTAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MORSE BALLOON INFLATION DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANGEION IGITAL ANGEFLATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENCORE 26 ADVANTAGE KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II IMMUNOASSAY.

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 AMPLICOR HCV TEST, VERSION 2.0

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AXSYM ANTI-HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

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 AMPLICOR HCV TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AXSYM ANTI-HCV

VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Steerable Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

STORM OPERATING KIT, MODEL 1-10-0

FDA 510(k)

FDA Class 2 ·Orthopedic

Steerable Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Patient Administration Set

FDA 510(k)

FDA Class 2 ·Radiology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR