PFC CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EP-WORKMATE

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD AUTOSHIELD PEN NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

ENCORE SS-A

FDA 510(k)

FDA Class 2 ·Immunology

THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR

FDA 510(k)

FDA Class 2 ·Microbiology

EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT

FDA 510(k)

FDA Class 2 ·Immunology

OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY

FDA 510(k)

FDA Class 2 ·Orthopedic

HOWMEDICA FULLY THREADED SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH

FDA 510(k)

FDA Class 2 ·Dental

DEGUFILL (TM) WHIT-SEALANT

FDA 510(k)

FDA Class 2 ·Dental

POTASSIUM TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Axis Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

SURGICAL RETRACTOR KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO PLAYTEX TAMPONS #24002

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

INFANT INCUBATOR

FDA 510(k)

FDA Class 2 ·General Hospital

HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS

FDA 510(k)

FDA Class 2 ·Hematology

PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE)

FDA 510(k)

FDA Class 2 ·Orthopedic

AUTOSCEPTOR

FDA 510(k)

FDA Class 2 ·Microbiology

MULTI DOPPLEX, MD-1

FDA 510(k)

FDA Class 2 ·Radiology