9 results
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6ms
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Sources: EU EUDAMED, US FDA
FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56
FDA Enforcement
Class II
·Ongoing·G & H Wire Company·February 14, 2024
ClubMax Laser Projection Series
FDA Enforcement
Class II
·Ongoing·Gk Photonics Inc·August 14, 2019
Atom Laser Projection Series
FDA Enforcement
Class II
·Ongoing·Gk Photonics Inc·August 14, 2019
Maxim Laser Projection Series
FDA Enforcement
Class II
·Ongoing·Gk Photonics Inc·August 14, 2019
Spectrum Laser Projection Series
FDA Enforcement
Class II
·Ongoing·Gk Photonics Inc·August 14, 2019
Burstberry Laser Projection Series
FDA Enforcement
Class II
·Ongoing·Gk Photonics Inc·August 14, 2019
Logolas Laser Projection Series
FDA Enforcement
Class II
·Ongoing·Gk Photonics Inc·August 14, 2019
Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure.
FDA Enforcement
Class II
·Ongoing·Berkeley Advanced Biomaterials, LLC·November 26, 2025
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·December 24, 2025