CardioLogs ECG Analysis Platform

FDA 510(k)

FDA Class 2 ·Cardiovascular

ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IDCAM Dental Implants

FDA 510(k)

FDA Class 2 ·Dental

EndoNaut

FDA 510(k)

FDA Class 2 ·Radiology

Withings Sleep Rx

FDA 510(k)

FDA Class 2 ·Anesthesiology

MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

ExactechGPS Total Shoulder Application, Equinoxe Planning Software

FDA 510(k)

FDA Class 2 ·Neurology

PIEZOTOME M+, PIEZOTOME M+ Handpiece

FDA 510(k)

FDA Class 2 ·Orthopedic

Activ Ankle

FDA 510(k)

FDA Class 2 ·Orthopedic

CINA

FDA 510(k)

FDA Class 2 ·Radiology

EmboCube Embolization Gelatin

FDA 510(k)

FDA Class 2 ·Cardiovascular

KODAK 9500

FDA 510(k)

FDA Class 2 ·Dental

Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Isocapnic Ventilation Device

FDA classification

FDA Class 2 ·Isocapnic Ventilation Device

Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System

Retrograde Intubation Set

FDA classification

FDA Class 2 ·Retrograde Intubation Set

Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System

Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions

FDA classification

FDA Class 2 ·Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions

Respirator, Surgical

FDA classification

FDA Class 2 ·Respirator, Surgical

Negative Pressure Wound Therapy Device For Reduction Of Wound Complications

FDA classification

FDA Class 2 ·Negative Pressure Wound Therapy Device For Reduction Of Wound Complications