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

MEDISURF

FDA 510(k)

FDA Class 1 ·Radiology

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

CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector

FDA 510(k)

FDA Class 2 ·Cardiovascular

V20 SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RENAISSANCE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Spectral CT

FDA 510(k)

FDA Class 2 ·Radiology

Medical diode laser systems (CHARISMA, REGAL)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery