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

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OPN XII UL

FDA 510(k)
FDA Class 2 ·Physical Medicine

OPN NC PTCA Dilatation Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex

FDA classification
FDA Class 2 ·Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex

AERONEB II, MODEL APN 200

FDA 510(k)
FDA Class 2 ·Anesthesiology

Erchonia DPN Laser (Model# EVRL)

FDA 510(k)
FDA Class 2 ·Physical Medicine

APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE

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

Thin Layer Chromatography, Propoxyphene

FDA classification
FDA Class 2 ·Thin Layer Chromatography, Propoxyphene

Bed, Pediatric Open Hospital

FDA classification
FDA Class 2 ·Bed, Pediatric Open Hospital

Snare, Rigid Self-Opening

FDA classification
FDA Class 2 ·Snare, Rigid Self-Opening

Electromechanical System For Open Microsurgery

FDA classification
FDA Class 2 ·Electromechanical System For Open Microsurgery

Adjunctive Open Loop Fluid Therapy Recommender

FDA classification
FDA Class 2 ·Adjunctive Open Loop Fluid Therapy Recommender

On-Body Injector

FDA classification
FDA Class 2 ·On-Body Injector

Device For Open Surgical Explant Of Endovascular Prostheses

FDA classification
FDA Class 2 ·Device For Open Surgical Explant Of Endovascular Prostheses

Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

FDA classification
FDA Class 2 ·Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

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