Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER LA-15 System

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix 035 Drug Coated Balloon PTA Catheter

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·THE PATH VYSION HER-2 DNA PRODE KIT

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval

FDA Class 3 ·UROVYSION BLADDER CANCER KIT ASSAY

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REAL TIME HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C TEST SERVICE

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·GELFOAM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HBV

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix 035 Drug Coated Balloon Catheter, Lutonix 018 Drug Coated Balloon Catheter

FDA Pre-Market Approval

BIO-SORB ABSORBABLE DUSTING POWDER

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix Drug Coated Balloon PTA Catheter

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·LUTONIX® 035 Drug Coated Balloon PTA Catheter

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK TEST SYSTEM

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

Lens, Contact (Polymethylmethacrylate)

FDA Pre-Market Approval

FDA Unclassified ·SATURN II(TM) (SYNERGICON A) CONTACT LENS

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HBV

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REAL TIME HCV GENOTYPE II, GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HBV assay

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CUSTOMFLEX CONTACT LENS