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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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141 to 150 of 416 results
Decision Date To: 06/01/2024
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Device Name
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De Novo
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510(k)
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Decision
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iTEAR Neurostimulator Olympic Ophthalmics, Inc. DEN190026 05/01/2020
OGmend Implant System Woven Orthopedic Technologies, LLC DEN180065 05/01/2020
CARPEDIEM System Bellco srl (now part of Medtronic, Inc) DEN180055 04/29/2020
MyCare Psychiatry Clozapine Assay Kit Saladax Biomedical Inc DEN190028 04/16/2020
iTind System Medi-Tate Ltd. DEN190020 02/25/2020
AmplideX Fragile X Dx & Carrier Screen K Asuragen, Inc. DEN190023 02/21/2020
Surfacer Inside-Out Access Catheter Syst Bluegrass Vascular Technologies, Inc. DEN190038 02/10/2020
Caption Guidance Bay Labs, Inc. DEN190040 02/07/2020
Mucosal Integrity Conductivity (MI) Test Diversatek Healthcare Inc. DEN180067 12/23/2019
Control-IQ Technology Tandem Diabetes Care, Inc. DEN190034 12/13/2019
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