Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

QUART ARTERIAL FILTER, MODEL HBF 140

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

BODY FAT ANALYZER, MODEL HBF-306

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

HBF-1000 OMRON BODY COMPOSITION ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MERLIN E-MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

MERLIN RESUSCITATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

JELDENT BASIC LINE

FDA 510(k)

FDA Class 2 ·Dental

THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET, THINKINGARCHIVE (OR NUPAX) - THE MANAGEMENT AND ARCHIV

FDA 510(k)

FDA Class 2 ·Radiology

Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System

FDA 510(k)

FDA Class 2 ·Orthopedic

Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System

FDA 510(k)

FDA Class 2 ·Orthopedic

TxTiHA IBF System, AxTiHA Stand-Alone ALIF System

FDA 510(k)

FDA Class 2 ·Orthopedic