EDWARDS SACRAL SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

Plato 17 Microcatheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Surgical Face Masks

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BI-ARTICULAR II HIP DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

extriCARE 1000 Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WORLDS BEST AND WORLDS BEST EXTRA SERIES (CONDOMS)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

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

MBA Biotech Implant System

FDA 510(k)

FDA Class 2 ·Dental

TOTAL LUNG EXERCISER (TLE)

FDA 510(k)

FDA Class 2 ·Anesthesiology

AEROBICA - LUNG EXERCISER

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)

ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC

FDA 510(k)

FDA Class 2 ·Orthopedic

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL