1,211 results · 29ms · Sources: EU EUDAMED, US FDA

On-Body Injector

FDA classification
FDA Class 2 ·On-Body Injector

Access PCT

FDA 510(k)
FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)
FDA Class 2 ·Microbiology

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)
FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)
FDA Class 2 ·Microbiology

Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen

FDA classification
FDA Class 2 ·Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen

Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

FDA classification
FDA Class 2 ·Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

FDA classification
FDA Class 2 ·Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

Device For Sleep Apnea Testing Based On Mandibular Movement

FDA classification
FDA Class 2 ·Device For Sleep Apnea Testing Based On Mandibular Movement

Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

FDA classification
FDA Class 2 ·Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

FDA classification
FDA Class 2 ·Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission