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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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21 to 30 of 415 results
Decision Date To: 05/24/2024
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Device Name
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Requester
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De Novo
Number
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510(k)
Number
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Decision
Date
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AMIGO REMOTE CATHETER SYSTEM CATHETER ROBOTICS INC DEN140009 12/18/2014
Amplichek II, Negative and Amplichek II, Bio-Rad Laboratories DEN150058 03/28/2016
AMPLICHIP CYP450 TEST, MODEL 04381866190 ROCHE MOLECULAR SYSTEMS, INC. DEN040011 K042259 12/23/2004
AmplideX Fragile X Dx & Carrier Screen K Asuragen, Inc. DEN190023 02/21/2020
Analytic for Hemodynamic Instability (AH Fifth Eye Inc. DEN200022 03/01/2021
APAS Compact with Urine Analysis Module CLEVER CULTURE SYSTEMS AG DEN150059 10/06/2016
APOLLO ESG System, APOLLO ESG SX System, Apollo Endosurgery, Inc. DEN210045 07/12/2022
Aptima Mycoplasma genitalium Assay Hologic, Inc. DEN180047 01/23/2019
APTIMA TRICHOMONAS VAGINALIS ASSAY GEN-PROBE INCORPORATED DEN110012 K102911 04/19/2011
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR APTUS ENDOSYSTEMS, INC. DEN100026 K102333 11/21/2011
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