BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set

FDA 510(k)

FDA Class 2 ·Physical Medicine

IPS e.max One

FDA 510(k)

FDA Class 2 ·Dental

Telio CAD Abutment Solutions- extra systems

FDA 510(k)

FDA Class 2 ·Dental

IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE

FDA 510(k)

FDA Class 2 ·Dental

Variolink Esthetic

FDA 510(k)

FDA Class 2 ·Dental

Project E Beauty LED Light Therapy Mask (Model: PE730)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED PTCA CATHETER

AIXPLORER

FDA 510(k)

FDA Class 2 ·Radiology

AIXPLORER

FDA 510(k)

FDA Class 2 ·Radiology

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

Light Based Treatment For Cold Sores Herpes Simplex Virus-1

FDA classification

FDA Class 2 ·Light Based Treatment For Cold Sores Herpes Simplex Virus-1

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