PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set

FDA 510(k)

FDA Class 2 ·General Hospital

LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Huber Needle Infusion Set, Safety Huber Needle Infusion Set

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO VF GEL PLUS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

VOCALIS GEL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·COBAS INTEGRA 400 PLUS CYCLOSPORINE

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys Anti-HCV II, PreciControl Anti-HCV

Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface

FDA 510(k)

FDA Class 2 ·Cardiovascular

PreferX Delivery System

FDA 510(k)

FDA Class 2 ·General Hospital

Tubing Pack

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tubing Pack

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affinity NT Oxygenator with Cortiva BioActive Surface

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

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

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP / COBAS TAQMAN CMV 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 TAQMAN HCV TEST, V2.0

Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II IMMUNOASSAY

FlexCath Advance Steerable Sheath and Dilator

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN CMV TEST