Vertex Hip Fracture Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

Advocate PTA Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Attune Revision Sleeve LPS Femoral Adaptors

FDA 510(k)

FDA Class 2 ·Orthopedic

Préime DermaFacial Collagen+

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Emerge Monorail PTCA Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294

FDA 510(k)

FDA Class 2 ·Neurology

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Zilver 635 Biliary Stent

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STRYKER ESSX MICRODEBRIDER SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

Préime DermaFacial (MicroT)

FDA 510(k)

FDA Class 2 ·Neurology

NEOCLOSE HASSON, NEOCLOSE UNIVERSAL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM™ NOILES™ Rotating Hinge Knee System; DePuy P.F.C. ™ SIGMA™ Total Knee System; DePuy SIGMA™ Total Knee System;

FDA 510(k)

FDA Class 2 ·Orthopedic

NEUROTECH MEDISTIM PLUS, TYPE 291

FDA 510(k)

FDA Class 2 ·Physical Medicine

Zilver 518 Biliary Stent, Zilver 635 Biliary Stent

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Telescope Guide Extension Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

AERONEB GO NEBULIZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

Soundly Anti Snoring Device

FDA 510(k)

FDA Class 2 ·Dental

Amylase2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry