17 results · 6ms · Sources: EU EUDAMED, US FDA

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Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

FDA classification
FDA Class 2 ·Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Monarch eTNS System

FDA 510(k)
FDA Class 2 ·Neurology

KINAMED CTN STEM

FDA 510(k)
FDA Class 2 ·Orthopedic

CT/N-II SCANNER SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

TITANIUM CANNULATED TIBIAL NAIL (TI CTN)

FDA 510(k)
FDA Class 2 ·Orthopedic

OPUS TROPONIN I (CTN) TEST MODULES

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®

FDA 510(k)
FDA Class 2 ·Neurology

CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL

FDA 510(k)
FDA Class 2 ·Orthopedic

Stimulator, Nerve

FDA classification
FDA Class 2 ·Stimulator, Nerve

Reservoir, Blood, Cardiopulmonary Bypass

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

On-Body Injector

FDA classification
FDA Class 2 ·On-Body Injector

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