MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00

FDA 510(k)

FDA Class 2 ·Neurology

NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NEUROSIGN 100 IMPEDANCE METER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NEUROSIGN AVALANCHE MOTOR NERVE MONITOR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NEUROSIGN MODEL 100

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NEUROSIGN LARYNGEAL ELECTRODES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Rapid Therapy System

FDA 510(k)

FDA Class 2 ·Neurology

NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED PTCA CATHETERS

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR AZTRENAM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX ESPRIT

Anovo Surgical System (Model 6Ne)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PROLINK ADHESIVES (PROLINK, PROLINK SE)

FDA 510(k)

FDA Class 2 ·Dental

NOVA Dental Implants System

FDA 510(k)

FDA Class 2 ·Dental

iTind System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PROFIL COMPOSITES (PROFIL, PROFIL FLOW)

FDA 510(k)

FDA Class 2 ·Dental

Anovo Surgical System (6Ne)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery