LATEX ULTRASONIC PROBE COVER

FDA 510(k)

FDA Class 2 ·Radiology

NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SancDam Latex Oral Dam

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·DERMABOND(R) TOPICAL SKIN ADHESIVE/HIGH VISCOSITY

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER (CAD) SYSTEM, M1000

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ONGUARD

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·INTER FIX THREADED FUSION DEVICE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·INTER FIX TM THREADED FUSION DEVICE

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·DTU-ONE ULTRASOUND SCANNER

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV READYPACKS

Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

FDA classification

FDA Class 2 ·Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·PowerLook® Tomo Detection Software