Panels, Test, Susceptibility, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·MIC ANTIBIOTIC TEST PANELS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·N-18 (KOLFOCON A),N-32 (KOLFOCON B) LENS MATERIAL

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

Analyzer, Body Composition, Exempt

FDA classification

FDA Class 2 ·Analyzer, Body Composition, Exempt

Catheter, Peritoneal Dialysis, Single Use, Exempt

FDA classification

FDA Class 2 ·Catheter, Peritoneal Dialysis, Single Use, Exempt

Tenaculum, Uterine, Exempt

FDA classification

FDA Class 2 ·Tenaculum, Uterine, Exempt

Drape, Surgical, Exempt

FDA classification

FDA Class 2 ·Drape, Surgical, Exempt

Wire, Guide, Catheter, Exempt

FDA classification

FDA Class 2 ·Wire, Guide, Catheter, Exempt

Biliary Catheter For Irrigation And Contrast Injection, Exempt

FDA classification

FDA Class 2 ·Biliary Catheter For Irrigation And Contrast Injection, Exempt

Reservoir, Blood, Cardiopulmonary Bypass, Exempt

FDA classification

FDA Class 2 ·Reservoir, Blood, Cardiopulmonary Bypass, Exempt

Computerized Cognitive Assessment Aid, Exempt

FDA classification

FDA Class 2 ·Computerized Cognitive Assessment Aid, Exempt

Scissors For Cytoscope, Exempt

FDA classification

FDA Class 2 ·Scissors For Cytoscope, Exempt