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U.S. Department of Health and Human Services

Medical Device Recalls

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510(K) Number: K223758
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EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE® device is a user controlled, stereo... 2 06/09/2025 QUANTUM SURGICAL SAS
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in t... 2 10/09/2024 QUANTUM SURGICAL SAS
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