ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

XPRESSE INJECTION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

SANICURE DISPOSABLE CURING PROBE

FDA 510(k)

FDA Class 2 ·Dental

OXFORD ANKLE FUSION NAIL(AFN) SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Eon Aligner

FDA 510(k)

FDA Class 2 ·Dental

ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

NELSON WATER SYSTEMS FOR HEMODIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BLUEDIAMOND IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

TiGEN Abutment, PMMA Abutment and Scan Healing Abutment

FDA 510(k)

FDA Class 2 ·Dental

ANAX™ OCT Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

XPERT MRSA

FDA 510(k)

FDA Class 2 ·Microbiology

XPERT MRSA/SA NASAL ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

NobelZygoma 45°

FDA 510(k)

FDA Class 2 ·Dental

CEP 8 SPECTRUMORANGE DNA PROBE KIT

FDA 510(k)

FDA Class 2 ·Immunology

Xpert VanA Assay

FDA 510(k)

FDA Class 2 ·Microbiology

GSS PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT

FDA 510(k)

FDA Class 2 ·Immunology

ARIX HAND SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ARIX FOOT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic