PROcedure Rehearsal Studio

FDA 510(k)

FDA Class 2 ·Radiology

LORENZ ORTHODONTIC ANCHORAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

1717FCC

FDA 510(k)

FDA Class 2 ·Radiology

HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC

FDA 510(k)

FDA Class 2 ·Radiology

TruAbutment DS

FDA 510(k)

FDA Class 2 ·Dental

ARIX Humerus System

FDA 510(k)

FDA Class 2 ·Orthopedic

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)

FDA 510(k)

FDA Class 2 ·Dental

SUPER NOVA, ACUBEAM

FDA 510(k)

FDA Class 2 ·Physical Medicine

GUA60A, GU60A-65

FDA 510(k)

FDA Class 2 ·Radiology

LORENZ 2.4 SELF DRILLING SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems

FDA 510(k)

FDA Class 2 ·Orthopedic

IMC SURGICAL FACE MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

URIS OMNI System

FDA 510(k)

FDA Class 2 ·Dental

GC85A

FDA 510(k)

FDA Class 2 ·Radiology

ACTIVO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA

FDA 510(k)

FDA Class 2 ·Radiology

HU/HS/HG PROSTHETIC SYSTEM

FDA 510(k)

FDA Class 2 ·Dental