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

XPERT C. DIFFICILE

FDA 510(k)

FDA Class 1 ·Microbiology

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

CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE

FDA 510(k)

FDA Class 2 ·Immunology

SNUCONE Tissue Level Implant System

FDA 510(k)

FDA Class 2 ·Dental

SECULOK™ ACP System

FDA 510(k)

FDA Class 2 ·Orthopedic

AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA

FDA 510(k)

FDA Class 1 ·Microbiology

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B

FDA 510(k)

FDA Class 1 ·Microbiology

N2

FDA 510(k)

FDA Class 1 ·Dental

AFFIRM PROCESSOR

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Huvitz Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

Infant Phototherapy Equipment

FDA 510(k)

FDA Class 2 ·General Hospital

TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment

FDA 510(k)

FDA Class 2 ·Dental

AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA

FDA 510(k)

FDA Class 1 ·Microbiology