Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories

FDA 510(k)

FDA Class 2 ·Radiology

Encompass 15 Channel Head Coil, 3T

FDA 510(k)

FDA Class 2 ·Radiology

Encompass SRS Headframe ; Encompass MR SRS Headframe

FDA 510(k)

FDA Class 2 ·Radiology

Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution

FDA 510(k)

FDA Class 2 ·Radiology

Iris AirShuttle™

FDA 510(k)

FDA Class 2 ·Radiology

kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening

FDA 510(k)

FDA Class 2 ·Radiology

Alta Multipurpose Device

FDA 510(k)

FDA Class 2 ·Radiology

Bfix Orthopedic External Fixator Systems

FDA 510(k)

FDA Class 2 ·Orthopedic

SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

R-X-FIX EXTERNAL FIXATOR

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO CONTOUR SE MICROSPHERES

FDA 510(k)

FDA Class 2 ·Neurology

DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DUS R-50S (Urine Chemistry system)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4

FDA 510(k)

FDA Class 2 ·Orthopedic

FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5

FDA 510(k)

FDA Class 2 ·Orthopedic

airVata™

FDA 510(k)

FDA Class 2 ·Dental

GENTLE COLON (REVISION 2.0)

FDA 510(k)

FDA Class 2 ·Radiology

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·INTER FIX THREADED FUSION DEVICE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·INTER FIX THREADED FUSION DEVICE