ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

Genesys Spine 3DP Cervical Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

Genesys Spine 3DP Lumbar Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

Genesys Spine 3DP Lumbar Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

BeneHold™ Surgical Incise Drape with CHG antimicrobial II

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OREGON SCINTIFIC

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITOSS-FILLED CARTRIDGE

FDA 510(k)

FDA Class 2 ·Orthopedic

Genesys Spine 3DP AIS-C II Cervical Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP

FDA 510(k)

FDA Class 2 ·Orthopedic

iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System

FDA 510(k)

FDA Class 2 ·Orthopedic

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

FDA 510(k)

FDA Class 2 ·Radiology

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software

FDA 510(k)

FDA Class 2 ·Microbiology

xTAG Cystic Fibrosis 39 Kit v2

FDA 510(k)

FDA Class 2 ·Immunology

xTAG Gastrointestinal Pathogen Panel (GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

CANDIDA DETECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology