Implant, Auditory Brainstem

FDA Pre-Market Approval

FDA Class 3 ·Nucleus AB1541 Auditory Brainstem Implant

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus 24 Cochlear Implant System

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·Nucleus Hybrid Cochlear Implant System

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Surgifoam Absorbable Gelatin Sponge, U.S.P.

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AFP/OB(TM) RIA KIT

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Versant HCV Genotype 2.0 Assay (LiPA)

Occluder, Internal Vessel, Temporary

FDA Pre-Market Approval

FDA Class 3 ·LEGOO

Barrier, Adhesion, Cardiovascular

FDA Pre-Market Approval

FDA Class 3 ·REPEL-CV BIORESORBABLE ADHESION BARRIER

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV Genotype 2.0 Assay (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Abbott Real Time HCV Genotype II Amplification Reagent Kit / HCV Genotype II Control Kit

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

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

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

Barrier, Adhesion, Cardiovascular

FDA Pre-Market Approval

FDA Class 3 ·REPEL-CV

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II ASSAY

Occluder, Internal Vessel, Temporary

FDA Pre-Market Approval

FDA Class 3 ·LEGOO ENDOVASCULAR OCCLUSION GEL

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II