BIOMET ACCESS SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DK*300 VOLUMETRIC INFUSION CONTROLLER

FDA 510(k)

FDA Class 2 ·General Hospital

MAXAN ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)

FDA 510(k)

FDA Class 2 ·Neurology

SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A

FDA 510(k)

FDA Class 2 ·Radiology

SNAP-LOCK ADDITIVE CAP #SL100

FDA 510(k)

FDA Class 2 ·General Hospital

SNAP-LOCK ADDITIVE CAP #SL 200

FDA 510(k)

FDA Class 2 ·General Hospital

IMAGE-IGE

FDA 510(k)

FDA Class 2 ·Immunology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT HAVAB/HAVAB EIA/IMX HAVAB

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·AUGMEN(TM) AKA SYNTHOGRAFT(TM) LG

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT HAVAB/HAVAB EIA/IMX HAVAB

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT COMMANDER(R) PPC AFP-EIA

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR NTDS

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER

Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

Triathlon Total Knee System-Additional Components

FDA 510(k)

FDA Class 2 ·Orthopedic

Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts

FDA 510(k)

FDA Class 2 ·Orthopedic

Restoration® Modular Hip System

FDA 510(k)

FDA Class 2 ·Orthopedic