SPEACELABS MULTIGAS MODULE

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPACELABS MEDICAL MULTIGAS ANALYZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

S2 Pigment Removal System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

Globe® Pulsed Field System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Versant HCV Genotype 2.0 Assay (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV Genotype 2.0 Assay (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Abbott Real Time HCV Genotype II Amplification Reagent Kit / HCV Genotype II Control Kit

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM