MITAKA POINT SETTER

FDA 510(k)

FDA Class 2 ·Neurology

Unscented Tampon

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DELTA 16 TACT

FDA 510(k)

FDA Class 2 ·Radiology

STAINLESS 22-13-5 SUTURE WIRE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HARRIS-GALANTE POROUS TOTAL HIP SYS

FDA 510(k)

FDA Class 2 ·Orthopedic

ENHANCED MODULAR AUSTIN MOORE HIP

FDA 510(k)

FDA Class 2 ·Orthopedic

The Red Head Collection Device, The Jordy Connection System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·\EART TRAK,HART TRAK III,MAX TRAK,MAX TRAK DP,PROA

LMT 20 HH LASER SURGIVAL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

URANUS, COMFORTOUCH LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LMT 20 AA LASER SURGICAL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LMT 40 AA LASER SURGICAL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·IMX AND AXSYM PSA

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX AFP ASSAY

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·IMX TACROLIMUS II ASSAY

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX(R) PSA*

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX TACROLIMUS II

VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME

FDA 510(k)

FDA Class 2 ·Immunology

INTEGRITY, MODEL V500

FDA 510(k)

FDA Class 2 ·Neurology