PASS OCT Patient Specific Rods

FDA 510(k)

FDA Class 2 ·Orthopedic

Yumizen C1200 CRP

FDA 510(k)

FDA Class 2 ·Immunology

DIP Arthrodesis System

FDA 510(k)

FDA Class 2 ·Orthopedic

Anthogyr Surgical Cassettes

FDA 510(k)

FDA Class 2 ·General Hospital

AXIOM REG

FDA 510(k)

FDA Class 2 ·Dental

ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ChestView US

FDA 510(k)

FDA Class 2 ·Radiology

Versatex Monofilament Mesh

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

JAZZ System, including JAZZ Band

FDA 510(k)

FDA Class 2 ·Orthopedic

ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

AEQUALIS FX2

FDA 510(k)

FDA Class 2 ·Orthopedic

Sim&Size

FDA 510(k)

FDA Class 2 ·Radiology

LERE NAIL & PLATE COMBIN. ONE PIECE FORGED

FDA 510(k)

FDA Class 2 ·Orthopedic

PREMIO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INTRAORAL DENTAL X-RAY SYSTEM 70-X

FDA 510(k)

FDA Class 2 ·Dental

Ankle Fusion Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

ICE COMPRESSION FIRST, DUO, & MOOVE Systems

FDA 510(k)

FDA Class 2 ·Physical Medicine

HERO 642

FDA 510(k)

FDA Class 1 ·Dental

CS Imaging

FDA 510(k)

FDA Class 2 ·Radiology

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD

FDA 510(k)

FDA Class 2 ·Microbiology