20 results
·
14ms
·
Sources: EU EUDAMED, US FDA
B1P ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
PULSE/B.P. MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
IDS-iSYS Ostase BAP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIGITAL ELECTRONIC B.P. MONITOR 2155
FDA 510(k)
FDA Class 2
·Cardiovascular
Béa Applicator (BAP-GB-01)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Bio Arterial Deluxe (IC-BAP-DX)
FDA 510(k)
FDA Class 2
·Cardiovascular
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
FDA 510(k)
FDA Class 2
·Radiology
Needle, Conduction, Anesthetic (W/Wo Introducer)
FDA classification
FDA Class 2
·Needle, Conduction, Anesthetic (W/Wo Introducer)
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
N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies
FDA classification
FDA Class 2
·N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies
Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
FDA classification
FDA Class 2
·Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay