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De Novo records

De Novo, Device, Requester table
De NovoDeviceRequesterProduct codeDecision date
DEN250057PCWP Analysis SoftwareSIF2026-05-22
DEN250028DeepView AI® SystemSHY2026-05-21
DEN250013Modius SperoSHX2026-05-08
DEN240075Prolystica Pass Thru Disinfectant Wipes2026-05-01
DEN250023Aurie SystemSHV2026-04-30
DEN250033XplantR Explant ToolSHR2026-04-17
DEN240071neuropacsSHO2026-04-03
DEN250014Tyto Insights for Eardrum Bulging DetectionSHL2026-03-17
DEN250012LifeVacQXN2026-03-04
DEN250007Delivery Date AISHE2026-02-11
DEN250006Amferia Wound DressingSHA2026-02-06
DEN250005Sana DeviceQYN2026-01-16
DEN250009VitaSmart Hypothermic Oxygenated Perfusion SystemSGY2026-01-15
DEN250004QIKCAP SystemSGX2025-12-23
DEN250032LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)SGW2025-12-23
DEN240077MuReva OM™SGQ2025-11-26
DEN250015Neurolyser XR (NXR100)SGN2025-11-14
DEN240074Pulsenmore ESSGJ2025-10-31
DEN240076Modius LeanSFW2025-10-17
DEN240073PainChek (PainChek Adult)SGB2025-10-06
DEN220077ProSense™ SystemQXW2025-10-03
DEN250016Essilor® Stellest®QUR2025-09-25
DEN240080Biolinq Shine Autonomous Time-in-Range MicrosensorSFU2025-09-23
DEN240067KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)SFS2025-09-19
DEN250002Delphi-MD SystemSFN2025-08-20
DEN240068ArteraAI ProstateSFH2025-07-31
DEN240066COAPTIUM Connect with TISSIUM LIGHTSFD2025-06-17
DEN240038Oxiplex®QVL2025-06-17
DEN240032APO-Easy Genotyping kitSFC2025-06-12
DEN240047Allix5SEZ2025-05-30
DEN240048Spur Peripheral Retrievable Stent SystemSEU2025-05-29
DEN240035ConcizuTrace™ ELISASES2025-05-22
DEN240045Teal WandSEP2025-05-09
DEN240062Minder SystemSEM2025-04-17
DEN240064CT-132SEE2025-04-11
DEN240021Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L); Model SAS-001-05 (XL))SEC2025-04-09
DEN240031Prapela SVS hospital bassinet pad (model P01)QVY2025-04-04
DEN240020Visby Medical Women's Sexual Health TestSEA2025-03-28
DEN240018CORIS SystemSEW2025-03-19
DEN230051MyoceneSDX2025-01-17