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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K890328
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ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Rig... 2 12/15/2023 Olympus Corporation of the Americas
Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone ... 2 07/21/2025 Olympus Corporation of the Americas
Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The ... 2 07/21/2025 Olympus Corporation of the Americas
Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700... 2 05/29/2018 Gyrus Acmi, Incorporated
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