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

Retrograde Intubation Set

FDA classification

FDA Class 2 ·Retrograde Intubation Set

Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

Catheter, Peritoneal, Long-Term Indwelling, Exempt

FDA classification

FDA Class 2 ·Catheter, Peritoneal, Long-Term Indwelling, Exempt

Assisted Reproduction Laminar Flow Workstation

FDA classification

FDA Class 2 ·Assisted Reproduction Laminar Flow Workstation

Tester, Auditory Impedance, Exempt

FDA classification

FDA Class 2 ·Tester, Auditory Impedance, Exempt

Colposcope (And Colpomicroscope), Exempt

FDA classification

FDA Class 2 ·Colposcope (And Colpomicroscope), Exempt

System, Peritoneal, Automatic Delivery, Exempt

FDA classification

FDA Class 2 ·System, Peritoneal, Automatic Delivery, Exempt

Tympanometer, Exempt

FDA classification

FDA Class 2 ·Tympanometer, Exempt

Analyzer, Nitrogen Dioxide, Exempt

FDA classification

FDA Class 2 ·Analyzer, Nitrogen Dioxide, Exempt