13 results · 69ms · Sources: EU EUDAMED, US FDA

ConcizuTrace™ ELISA

FDA registration
RANDOX LABORATORIES LIMITED·1 product·🇬🇧 United Kingdom

ConcizuTrace™ ELISA

FDA registration
RANDOX LABORATORIES LIMITED·1 product·🇬🇧 United Kingdom

ConcizuTrace™ ELISA

FDA 510(k)
FDA Class 2 ·Hematology

Non-Factor Replacement Product Test System

FDA classification
FDA Class 2 ·Non-Factor Replacement Product Test System

BEAR® (Bridge-Enhanced ACL Repair) Implant

FDA registration
MIACH ORTHOPAEDICS·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 registration
HOLOGIC, 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

“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”

FDA 510(k)
FDA Class 2 ·Pathology

BEAR (Bridge-Enhanced ACL Repair) Implant

FDA 510(k)
FDA Class 2 ·Orthopedic

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

Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair

FDA classification
FDA Class 2 ·Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair