CARTO ENT System

FDA 510(k)

FDA Class 2 ·Neurology

TruDi® Navigation System V3 (FG-2000-00)

FDA 510(k)

FDA Class 2 ·Neurology

MALLEABLE SUCTION INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Neurology

TruDi Navigation System

FDA 510(k)

FDA Class 2 ·Neurology

EM ENT Navigated Suctions

FDA 510(k)

FDA Class 2 ·Neurology

GuideWire

FDA 510(k)

FDA Class 2 ·Neurology

MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020

FDA 510(k)

FDA Class 2 ·Neurology

Suture, Nonabsorbable, Synthetic, Polypropylene

FDA Pre-Market Approval

FDA Class 2 ·GORE-TEX(TM) SUTURE

MULTIX Impact

FDA 510(k)

FDA Class 2 ·Radiology

MAGNETOM Vida

FDA 510(k)

FDA Class 2 ·Radiology

MAGNETOM Skyra Fit

FDA 510(k)

FDA Class 2 ·Radiology

MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software

FDA 510(k)

FDA Class 2 ·Radiology

MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit

FDA 510(k)

FDA Class 2 ·Radiology

Somatom Confidence ® RT Pro

FDA 510(k)

FDA Class 2 ·Radiology

Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch

FDA 510(k)

FDA Class 2 ·Radiology

syngo.CT Single Source Dual Energy (Twin Beam)

FDA 510(k)

FDA Class 2 ·Radiology

Mammomat Fusion with Stereotactic Biopsy

FDA 510(k)

FDA Class 2 ·Radiology

syngo. CT Single Source Dual Energy (twin beam)

FDA 510(k)

FDA Class 2 ·Radiology

MAGNETOM Terra

FDA 510(k)

FDA Class 2 ·Radiology

syngo.CT Extended Functionality

FDA 510(k)

FDA Class 2 ·Radiology