SCANDINAVIAN IVF SCIENCES AB, G1.2

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Captiva Spine FuselOX Cervical IBF System

FDA 510(k)

FDA Class 2 ·Orthopedic

MATRIX HA PEEK Cervical IBF System

FDA 510(k)

FDA Class 2 ·Orthopedic

Vy Spine ClariVy Cervical IBF System

FDA 510(k)

FDA Class 2 ·Orthopedic

PIONEER CROSSFUSE II IBF/VBR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

HAtetracell™-C Titanium Cervical IBF System

FDA 510(k)

FDA Class 2 ·Orthopedic

COALIGN INNOVATIONS ACCULIF XL IBF CAGE

FDA 510(k)

FDA Class 2 ·Orthopedic

UniVy™ OsteoVy™-Ti Cervical IBF System

FDA 510(k)

FDA Class 2 ·Orthopedic

IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS

FDA 510(k)

FDA Class 2 ·Dental

EchoSolv AS

FDA 510(k)

FDA Class 2 ·Radiology

BC100 BODY COMPOSITION ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IQ TECHNOLOGIES

FDA 510(k)

FDA Class 2 ·Neurology

CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IQ Technologies

FDA 510(k)

FDA Class 2 ·Neurology

Talos® Lumbar (HA) PEEK IBF Devices

FDA 510(k)

FDA Class 2 ·Orthopedic

Matrix HA Fusion Porous Cervical IBF System

FDA 510(k)

FDA Class 2 ·Orthopedic

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·SUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK)

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM