405 results · 19ms · Sources: EU EUDAMED, US FDA

CANDIDA ALBICANS, ANTISERUM

FDA 510(k)
FDA Class 2 ·Microbiology

COCCIDIOIDES IMMITIS, ANTIGEN

FDA 510(k)
FDA Class 2 ·Microbiology

Tetraphenyl Borate, Colorimetry, Potassium

FDA classification
FDA Class 2 ·Tetraphenyl Borate, Colorimetry, Potassium

Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

FDA classification
FDA Class 2 ·Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

Isocapnic Ventilation Device

FDA classification
FDA Class 2 ·Isocapnic Ventilation Device

Retrograde Intubation Set

FDA classification
FDA Class 2 ·Retrograde Intubation Set

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

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

FDA classification
FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

FDA classification
FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

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