PROXIMAL HUMERAL REPLACEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODEL SCR-1000

FDA 510(k)

FDA Class 2 ·Cardiovascular

Spirair Nasal Septal Strap

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

NEUROQ 3.6

FDA 510(k)

FDA Class 2 ·Radiology

JINTRONIX REHABILITATION SYSTEM (JRS)

FDA 510(k)

FDA Class 2 ·Physical Medicine

ELLEX INNOVATIVE IMAGING EYE CUBED V4

FDA 510(k)

FDA Class 2 ·Radiology

HEARTPORT NEEDLE TROCAR

FDA 510(k)

FDA Class 2 ·Cardiovascular

NeoTract UroLift System UL500

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled

FDA 510(k)

FDA Class 2 ·Cardiovascular

PLS MINI

FDA 510(k)

FDA Class 2 ·General Hospital

CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

FDA 510(k)

FDA Class 2 ·Neurology

CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PROSTIVA RF THERAPY HAND PIECE, MODEL 8929

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MRIaudio PREM System with MRIview

FDA 510(k)

FDA Class 2 ·Radiology

FEF(TM) END-TIDAL CO2 DETECTOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIDECO-SHILEY UNIVERSAL Y

FDA 510(k)

FDA Class 2 ·Anesthesiology

VICRYL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery