HEALTHEPOD

FDA 510(k)

FDA Class 2 ·Cardiovascular

SCANVIEW HER2/NEU FISH SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

AQUABOND ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

LungVision Tool

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire

FDA 510(k)

FDA Class 2 ·Orthopedic

BriefCase

FDA 510(k)

FDA Class 2 ·Radiology

Epitomee

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CarboClear® Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

NeuroTrigger Basic (NTB)

FDA 510(k)

FDA Class 2 ·Physical Medicine

XELERIS 3 PROCESSING AND REVIEW WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

DUET DRF

FDA 510(k)

FDA Class 2 ·Radiology

OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENVOY PATIENT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)

FDA 510(k)

FDA Class 2 ·Orthopedic

LEGIONELLA PNEUMOPHILA

FDA 510(k)

FDA Class 2 ·Microbiology

XACT Robotic System

FDA 510(k)

FDA Class 2 ·Radiology

Lumenis M22 System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery