SINGLE USE MANOMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)

FDA 510(k)

FDA Class 2 ·Anesthesiology

FLEXICARE BREATHING FILTERS

FDA 510(k)

FDA Class 2 ·Anesthesiology

FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE

FDA 510(k)

FDA Class 2 ·Anesthesiology

Flexicare Heated Wire Breathing Systems

FDA 510(k)

FDA Class 2 ·Anesthesiology

Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20

FDA 510(k)

FDA Class 2 ·Anesthesiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·HARTZLER ACX II(R) CORONARY DILATATION CATHETER

FilmArray Pneumonia Panel plus

FDA 510(k)

FDA Class 2 ·Pathology

BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)

FDA 510(k)

FDA Class 2 ·Pathology

FilmArray Pneumonia Panel plus

FDA 510(k)

FDA Class 2 ·Pathology

AirRay Subdural Cortical Electrodes

FDA 510(k)

FDA Class 2 ·Neurology

GammaBeam 100

FDA 510(k)

FDA Class 2 ·Radiology

ARVIS Surgical Navigation System

FDA 510(k)

FDA Class 2 ·Neurology

CYRTINA SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

CAMCERAM TCP

FDA 510(k)

FDA Class 2 ·Orthopedic

NextDent Base

FDA 510(k)

FDA Class 2 ·Dental

GammaBeam 500

FDA 510(k)

FDA Class 2 ·Radiology

Composite Orthodontic Brackets and Buttons

FDA 510(k)

FDA Class 2 ·Dental

Automated Digital Image Manual Interpretation Microscope

FDA classification

FDA Class 2 ·Automated Digital Image Manual Interpretation Microscope