Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G INSULIN PUMP

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY HER-2/NEU (CLONE CD11) PRIMARY ANTIBODY

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA classification

FDA Class 3 ·Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA classification

FDA Class 3 ·System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

Absorbable Coronary Drug-Eluting Stent

FDA classification

FDA Class 3 ·Absorbable Coronary Drug-Eluting Stent

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA classification

FDA Class 3 ·Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

Hybrid Stent Graft, Thoracic Aortic Lesion Treatment

FDA classification

FDA Class 3 ·Hybrid Stent Graft, Thoracic Aortic Lesion Treatment

Coronary Drug-Eluting Stent

FDA classification

FDA Class 3 ·Coronary Drug-Eluting Stent

Stent, Superficial Femoral Artery, Drug-Eluting

FDA classification

FDA Class 3 ·Stent, Superficial Femoral Artery, Drug-Eluting

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ENPULSE INPLANTABLE PULSE GENERATOR

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·GUARDIAN REAL-TIME AND PARADIGM REAL-TIME SYSTEMS

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME SYSTEM AND GUARDIAN REAL-TIME SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·GUARDIAN REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM

Immunohistochemistry Assay, Antibody, Met

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Met

Immunohistochemistry Assay, Antibody, Claudin 18

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Claudin 18

Immunohistochemistry Assay, Antibody, Folr1

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Folr1

Stimulator, Low Electric Field, Tumor Treatment

FDA classification

FDA Class 3 ·Stimulator, Low Electric Field, Tumor Treatment

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA classification

FDA Class 3 ·Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase