Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-AB-HAVK PLUS

Aquaporin-4 Autoantibody

FDA classification

FDA Class 2 ·Aquaporin-4 Autoantibody

Cpr Aid Feedback Device (No Software)

FDA classification

FDA Class 2 ·Cpr Aid Feedback Device (No Software)

XVbeam2000

FDA 510(k)

FDA Class 2 ·Dental

Intravascular Administration Set, Automated Air Removal System

FDA classification

FDA Class 2 ·Intravascular Administration Set, Automated Air Removal System

System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

FDA classification

FDA Class 2 ·System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

Assay For Detection Of Proteases In Chronic Wounds

FDA classification

FDA Class 2 ·Assay For Detection Of Proteases In Chronic Wounds

Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

FDA classification

FDA Class 2 ·Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

Bone Sonometer

FDA classification

FDA Class 2 ·Bone Sonometer

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

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 HEPATITIS C VIRUS (HCV) TEST

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY TFC UNITE PRODUCT LINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ICAD SYSTEM