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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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161 to 170 of 416 results
Decision Date To: 06/08/2024
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Device Name
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De Novo
Number
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510(k)
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Decision
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BEAR (Bridge-Enhanced ACL Repair) Implan Miach Orthopaedics, Inc. DEN200035 12/16/2020
Alethia CMV DNA Amplification Assay, Ale Meridian Bioscience, Inc. DEN180040 11/30/2018
MSK-IMPACT (Integrated Mutation Profilin Memorial Sloan-Kettering Cancer Center DEN170058 11/15/2017
Hominis Surgical System Memic Innovative Surgery Ltd. DEN190022 02/26/2021
Medtronic DUET External Drainage and Mon MEDTRONIC NEUROSURGERY DEN120017 08/22/2014
SureTune4 Software Medtronic Neuromodulation DEN210003 08/23/2021
Medline ART Skin Harvesting System Medline Industries, Inc DEN210049 03/27/2024
Comfort Marker 2.0. Medical Precision B.V. DEN200041 12/10/2021
iTind System Medi-Tate Ltd. DEN190020 02/25/2020
PMD-200 Medasense Biometrics Ltd. DEN210022 02/17/2023
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