DePuy Actis DuoFix Hip Prosthesis

FDA 510(k)

FDA Class 2 ·Orthopedic

Nexstim Navigated Brain Therapy (NBT) System 2

FDA 510(k)

FDA Class 2 ·Neurology

Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm

FDA 510(k)

FDA Class 2 ·Physical Medicine

PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EMBOTRAP III Revascularization Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

BionicGym Powered Muscle Stimulator

FDA 510(k)

FDA Class 2 ·Physical Medicine

Volumetric/Manometric, Carbon-Dioxide

FDA classification

FDA Class 2 ·Volumetric/Manometric, Carbon-Dioxide

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Instruments Designed For Press-Fit Osteochondral Implants

FDA classification

FDA Class 2 ·Instruments Designed For Press-Fit Osteochondral Implants

Self-Fitting Air-Conduction Hearing Aid, Prescription

FDA classification

FDA Class 2 ·Self-Fitting Air-Conduction Hearing Aid, Prescription

Self-Fitting Air-Conduction Hearing Aid, Over The Counter

FDA classification

FDA Class 2 ·Self-Fitting Air-Conduction Hearing Aid, Over The Counter

Wheelchair, Stair Climbing

FDA classification

FDA Class 2 ·Wheelchair, Stair Climbing

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

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HEPATITIS C VIRUS (HCV) TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLICOR HCV TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·AFFINITY ANTERIOR CERVICAL CAGE SYSTEM