3 results
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15ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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CEI Cutting Edge Instruments (PTC-57C)
FDA Enforcement
Class II
·Ongoing·Coltene Whaledent Inc·November 25, 2020
Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
FDA Enforcement
Class II
·Ongoing·The See Clear Company·March 15, 2017
Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio¿ Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona¿ Personalized Knee System.
FDA Enforcement
Class II
·Ongoing·Canary Medical, Inc.·July 16, 2025