16 results · 7ms · Sources: EU EUDAMED, US FDA

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OnX Tough

FDA 510(k)
FDA Class 2 ·Dental

ONX Large External Fixation System

FDA 510(k)
FDA Class 2 ·Orthopedic

Ovarian Adnexal Mass Assessment Score Test System

FDA classification
FDA Class 2 ·Ovarian Adnexal Mass Assessment Score Test System

Viz ANEURYSM, Viz ANX

FDA 510(k)
FDA Class 2 ·Radiology

BNX FINE NEEDLE ASPIRATION SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

BNX Fine Needle Aspiration System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED,

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Lead, Protoporphyrin Zinc Method, Fluorometric

FDA classification
FDA Class 2 ·Lead, Protoporphyrin Zinc Method, Fluorometric

On-Body Injector

FDA classification
FDA Class 2 ·On-Body Injector

Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

FDA classification
FDA Class 2 ·Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

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

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

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

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