Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph

FDA 510(k)

FDA Class 2 ·Radiology

SMR Hybrid Glenoid System

FDA 510(k)

FDA Class 2 ·Orthopedic

JOURNEY INCLINED PLATFORM LIFT AND SUPRA CURVED INCLINE PLATFORM LIFT

FDA 510(k)

FDA Class 2 ·Physical Medicine

Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring

FDA 510(k)

FDA Class 2 ·Cardiovascular

NIRVANA

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FISIOWARM 7.0

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MN-111

FDA 510(k)

FDA Class 2 ·General Hospital

Physiq

FDA 510(k)

FDA Class 2 ·Physical Medicine

Discovery Pico; Discovery Pico Plus; Discovery Pico Derm

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Empower H100, Cyber Ho 100, Litho 100

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HD+12, HD+15

FDA 510(k)

FDA Class 2 ·Cardiovascular

MIR SPIROBANK SPIROMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

FDA 510(k)

FDA Class 2 ·Radiology

Revision Femoral Stem

FDA 510(k)

FDA Class 2 ·Orthopedic

Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)

FDA 510(k)

FDA Class 2 ·Radiology

FITBONE® Transport and Lengthening System

FDA 510(k)

FDA Class 2 ·Orthopedic

Fitbone Trochanteric

FDA 510(k)

FDA Class 2 ·Orthopedic

Medical RF

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Physica PS Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic