2 results
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20ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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ULTRA Telescopes
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
FDA Enforcement
Class II
·Ongoing·Heraeus Medical GmbH (Dental Division)·January 21, 2026