WHISPER O2

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

BBP BONE SUBSTITUTES

FDA 510(k)

FDA Class 2 ·Dental

TOMTEC ECHO-SCAN

FDA 510(k)

FDA Class 2 ·Radiology

WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS

FDA 510(k)

FDA Class 2 ·General Hospital

STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

STEAM/EO RECORD CARD, MODEL CI 121

FDA 510(k)

FDA Class 2 ·General Hospital

Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4

FDA 510(k)

FDA Class 2 ·Neurology

COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FORCEGUARD

FDA 510(k)

FDA Class 2 ·Physical Medicine

THYROSAMPLER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System

FDA 510(k)

FDA Class 2 ·General Hospital

THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES)

FDA 510(k)

FDA Class 2 ·Neurology

ELECTROSURGICAL DISPERSIVE ELECTRODE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PlumeSafe X5 Smoke Management System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO LANX SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK

FDA 510(k)

FDA Class 2 ·Cardiovascular

SEALED LEAD ACID BATTERY PACK

FDA 510(k)

FDA Class 2 ·Radiology