2 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog, REF 9002003 Astra-compatible 3.0mm Digital Analog, REF 9002103 Astra-compatible Aqua 3.5/4.0mm Digital Analog, REF 9002203 Astra-compatible Lilac 4.5/5.0mm Digital Analog, REF 9002203 BioHorizons¿-compatible 3.0mm Digital Analog, REF 9005203 Legacy-compatible 3.0mm Digital Analog, REF 9005303 Digital Analog - BioHorizons - 3.5mm, Digital Analog - BioHorizons¿ - 4.5mnm, REF 9005403 Legacy-compatible 3.5mm Digital Analog, REF 9005503 Legacy-compatible 5.7mm Digital Analog, REF 9008503 Astra EV 4.8mm Milled Titanium Abutment REF 9006767 Digital analogs are used for visual inspection of abutments and restoration in the dental laboratory.
FDA Enforcement
Class II
·Ongoing·Preat Corp·August 28, 2024
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024