FDA 510(k) Clearances
510(k) cleared devices tracked by MedTracker
QXM
2025-12-12
DTZ
2025-12-12
Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)
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EMA
2025-12-12
TopCEM Vigor SA Self-Adhesive Resin Cement
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NUC
2025-12-12
Cerynë Intimate Care
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GEX
2025-12-12
Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)
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DZE
2025-12-12
Pterygoid Indication for GM Helix Implants
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NEU
2025-12-12
VizMark Preloaded Tissue Marker Device (VM-0001)
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NPL
2025-12-12
Jason membrane
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NHN
2025-12-12
Therapy US
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FRG
2025-12-12
Self-Seal Sterilization Pouch and Roll
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HKI
2025-12-12
Fundus On Phone Non Mydriatic (FOP NM-10)
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HSB
2025-12-12
Affixus® Natural Nail® Proximal Humeral System
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