AIXPLORER

FDA 510(k)

FDA Class 2 ·Radiology

AIXPLORER

FDA 510(k)

FDA Class 2 ·Radiology

GALEMED PEAK FLOW METER, MODELS 3751/3752

FDA 510(k)

FDA Class 2 ·Anesthesiology

Device, Mixing And Weighing, Semi-Automated

FDA classification

FDA Class 2 ·Device, Mixing And Weighing, Semi-Automated

Thin Layer Chromatography, Phenobarbital

FDA classification

FDA Class 2 ·Thin Layer Chromatography, Phenobarbital

Bromcresol Green Dye-Binding, Albumin

FDA classification

FDA Class 2 ·Bromcresol Green Dye-Binding, Albumin

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·PALACOS E-FLOW (OSTEOPAL) BONE CEMENT

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA DIMENSIONS 2D MOBILE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Ventilator, Continuous, Minimal Ventilatory Support, Home Use

FDA classification

FDA Class 2 ·Ventilator, Continuous, Minimal Ventilatory Support, Home Use

Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

FDA classification

FDA Class 2 ·Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

Implant, Endosseous, Orthodontic

FDA classification

FDA Class 2 ·Implant, Endosseous, Orthodontic

Digital Pathology Image Viewing And Management Software

FDA classification

FDA Class 2 ·Digital Pathology Image Viewing And Management Software

Control Material, Blood Circulating Epithelial Cancer Cell

FDA classification

FDA Class 2 ·Control Material, Blood Circulating Epithelial Cancer Cell

Cervical Intraepithelial Neoplasia (Cin) Test System

FDA classification

FDA Class 2 ·Cervical Intraepithelial Neoplasia (Cin) Test System

Automated Digital Image Manual Interpretation Microscope

FDA classification

FDA Class 2 ·Automated Digital Image Manual Interpretation Microscope

Whole Slide Imaging System

FDA classification

FDA Class 2 ·Whole Slide Imaging System

Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis

FDA classification

FDA Class 2 ·Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis