SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE

FDA 510(k)

FDA Class 2 ·Dental

SIVR56-T KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

DR 800 with DSA, DR 800

FDA 510(k)

FDA Class 2 ·Radiology

Mimics Cardiac Planner

FDA 510(k)

FDA Class 2 ·Radiology

Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

FDA 510(k)

FDA Class 2 ·Orthopedic

CORONIS 3MP

FDA 510(k)

FDA Class 2 ·Radiology

SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS

FDA 510(k)

FDA Class 2 ·Dental

SIGNATURE PLANNER; SIGNATURE GUIDES

FDA 510(k)

FDA Class 2 ·Orthopedic

ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35)

FDA 510(k)

FDA Class 2 ·Orthopedic

MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES

FDA 510(k)

FDA Class 2 ·Orthopedic

Nio Color 8MP (MDNC-8132)

FDA 510(k)

FDA Class 2 ·Radiology

DX-D Imaging Package with XD Detectors

FDA 510(k)

FDA Class 2 ·Radiology

MIMICS

FDA 510(k)

FDA Class 2 ·Radiology

Mammo Tomosynthesis (MDMG-5221)

FDA 510(k)

FDA Class 2 ·Radiology

DR 800 with Tomosynthesis

FDA 510(k)

FDA Class 2 ·Radiology

SURGICASE ORTHOGNATHIC SOFTWARE WIZARD

FDA 510(k)

FDA Class 2 ·Radiology

SURGICASE CONNECT, SURGICASE GUIDE

FDA 510(k)

FDA Class 2 ·Orthopedic

ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER

FDA 510(k)

FDA Class 2 ·Orthopedic

SURGICASE GUIDE

FDA 510(k)

FDA Class 2 ·Neurology

Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)

FDA 510(k)

FDA Class 2 ·Microbiology