KCP PAK CONVENIENCE PACK

FDA 510(k)

FDA Class 2 ·Ophthalmic

KCP PAK #2 CONVENIENCE PACK MODIFICATION

FDA 510(k)

FDA Class 2 ·Ophthalmic

KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA

FDA 510(k)

FDA Class 2 ·Ophthalmic

Anchorage 2 CP System

FDA 510(k)

FDA Class 2 ·Orthopedic

WALLACE INTRAUTERINE INSEMINATION CATHETER

FDA 510(k)

FDA Class 2 ·Dental

ECP HEALTH SYSTEM, MODEL 2005

FDA 510(k)

FDA Class 2 ·Cardiovascular

BladderScan Prime System

FDA 510(k)

FDA Class 2 ·Radiology

HydroMARK Breast Biopsy Site Markers

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System

FDA 510(k)

FDA Class 2 ·Physical Medicine

FACE TANNER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SUN TANNING BED

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

I-Motion

FDA 510(k)

FDA Class 2 ·Physical Medicine

IMMUNOSCAN RA ANTI-CCP TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE CCP3.1 IGG/IGA ELISA

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA

FDA 510(k)

FDA Class 2 ·Immunology

EDIA ANTI-CCP

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANTI-CCP ELISA

FDA 510(k)

FDA Class 2 ·Immunology

CCPOINT

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE 2000 ANTI-CCP IGG ASSAY

FDA 510(k)

FDA Class 2 ·Immunology