12 results
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47ms
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Sources: EU EUDAMED, US FDA
Genius Digital Diagnostics System with the Genius Cervical AI algorithm
FDA registration
Hologic, Inc.·1 product·🇺🇸 United States
Genius Digital Diagnostics System with the Genius Cervical AI algorithm
FDA registration
HOLOGIC, INC.·1 product·🇺🇸 United States
Genius Digital Diagnostics System with the Genius Cervical AI algorithm
FDA 510(k)
FDA Class 2
·Pathology
Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
FDA classification
FDA Class 2
·Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
BEAR® (Bridge-Enhanced ACL Repair) Implant
FDA registration
MIACH ORTHOPAEDICS·1 product·🇺🇸 United States
Luminopia One
FDA registration
LUMINOPIA INC·1 product·🇺🇸 United States
Isomedix Operations Inc.
FDA registration
Isomedix Operations Inc.·1 product·🇺🇸 United States
DSM Biomedical, Inc.
FDA registration
DSM Biomedical, Inc.·1 product·🇺🇸 United States
BEAR (Bridge-Enhanced ACL Repair) Implant
FDA 510(k)
FDA Class 2
·Orthopedic
Luminopia One
FDA 510(k)
FDA Class 2
·Ophthalmic
Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
FDA classification
FDA Class 2
·Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
Digital Therapy Device For Amblyopia
FDA classification
FDA Class 2
·Digital Therapy Device For Amblyopia