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

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Tent, Oxygen, Electrically Powered

FDA classification
FDA Class 2 ·Tent, Oxygen, Electrically Powered

EUROTAN BY AYK

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

BAK-ON SP PORCELAIN ALLOY

FDA 510(k)
FDA Class 2 ·Dental

MODIFICATION TO BONE ANCHOR AND KIT (BAK)

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

BK-A; BK-B; BK-IS SEALING CAP

FDA 510(k)
FDA Class 2 ·Cardiovascular

AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK)

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

Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE)

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)

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

Cuff, Tracheal Tube, Inflatable

FDA classification
FDA Class 2 ·Cuff, Tracheal Tube, Inflatable

Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna

FDA classification
FDA Class 2 ·Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna

Red-Cell Count By Photometry

FDA classification
FDA Class 2 ·Red-Cell Count By Photometry

Rinse, Oral, Antibacterial (By Physical Means)

FDA classification
FDA Class 2 ·Rinse, Oral, Antibacterial (By Physical Means)

Image Acquisition And/Or Optimization Guided By Artificial Intelligence

FDA classification
FDA Class 2 ·Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Ultrasound Imaging System For Acquiring Images At Home By Lay Users

FDA classification
FDA Class 2 ·Ultrasound Imaging System For Acquiring Images At Home By Lay Users

Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

FDA classification
FDA Class 2 ·Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

FDA classification
FDA Class 2 ·Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.

FDA classification
FDA Class 2 ·Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.

Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

FDA classification
FDA Class 2 ·Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

FDA classification
FDA Class 2 ·Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

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