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

MOBILE C-ARM OMNI 325

FDA 510(k)

FDA Class 2 ·Radiology

PASCO MIC AND MIC/ID PANELS (CEFEPIME)

FDA 510(k)

FDA Class 2 ·Microbiology

PASCO MIC AND MIC/ID PANELS

FDA 510(k)

FDA Class 2 ·Microbiology

Biomet Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

OSTEOGRAF/N NATURAL HYDROXYLAPATITE, 40-60 MESH

FDA 510(k)

FDA Class 2 ·Dental

COBE CENTRYSYSTEM 3 BICART OPTION KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)

FDA 510(k)

FDA Class 2 ·Cardiovascular