POWERED WHEELCHAIR, MODEL B-500

FDA 510(k)

FDA Class 2 ·Physical Medicine

POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS

FDA 510(k)

FDA Class 2 ·Neurology

DPOAE20 , ECLIPSE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ROTATION MEDICAL BONE STAPLE (RMB STAPLE)

FDA 510(k)

FDA Class 2 ·Orthopedic

VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

AVI GUARDIAN MICRO 410 INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

BIOPRO - INFINITY PLATE ANCHOR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BD MAX CT/GC/TV 20-Day QC Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Vitrea, Version 7.0 Medical Image Processing Software

FDA 510(k)

FDA Class 2 ·Radiology

superDimension Navigation System

FDA 510(k)

FDA Class 2 ·Radiology

iLab Polaris Multi-Modality Guidance System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac

FDA 510(k)

FDA Class 2 ·Cardiovascular

RAYLOR(TM) DRILL STOP

FDA 510(k)

FDA Class 2 ·Neurology

Pounce™ Sheath

FDA 510(k)

FDA Class 2 ·Cardiovascular

OptiCross™ 18 Peripheral Imaging Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Affinity Fusion™ Oxygenator System

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005

FDA 510(k)

FDA Class 2 ·Cardiovascular

DAS SPORT PUMP(TM)

FDA 510(k)

FDA Class 2 ·Physical Medicine

VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO-MEDICUS BIO CONSOLE MODELS 540 A B C

FDA 510(k)

FDA Class 2 ·Cardiovascular