Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

Medtronic Navigation, Inc.

FDA 510(k) & PMA Approved Dispositivos — 24 products

Total de dispositivos24
Categorías0
Última decisión de la FDA
TipoNúmeroNombre del dispositivoCódigoFechaAcciones
510(k) K253379 Stealth AXiS Cranial clinical applicationHAW2026-03-26 Ver
510(k) K253395 Stealth AXiS™ ENT clinical applicationPGW2026-03-16 Ver
510(k) K253391 Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)ONO2026-03-13 Ver
510(k) K253381 Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationOLO2026-02-12 Ver
510(k) K251282 StealthStation S8 Spine SoftwareOLO2025-10-17 Ver
510(k) K242464 Stealth™ Spine Clamps; ModuLeX™ Shank MountsOLO2025-06-05 Ver
510(k) K240465 O-arm O2 Imaging SystemOWB2024-06-21 Ver
510(k) K231976 StealthStation Cranial Software, v3.1.5 (9735585)HAW2023-10-19 Ver
510(k) K221087 Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4HAW2022-06-10 Ver
510(k) K211269 Sistema de Ablación por Laser Guiado por RM Visualase (SW 3.4)ONO2022-01-07 Ver
510(k) K203639 StealthStation Cranial Software v1.3.2HAW2021-01-13 Ver
510(k) K200723 StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)PGW2020-06-26 Ver
510(k) K201175 StealthStation Cranial Software v1.3.0HAW2020-06-03 Ver
510(k) K201189 Stealthstation S8 Spine Software v1.3.0OLO2020-05-29 Ver
510(k) K191597 Stealth Autoguide System, Midas Rex Legend Depth Stop SystemHAW2019-11-01 Ver
510(k) K190672 StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1HAW2019-07-31 Ver
510(k) K181859 Visualase Thermal Therapy SystemLLZ2019-03-06 Ver
510(k) K170018 Software StealthStationTM S8 ENTPGW2017-05-19 Ver
510(k) K162655 StealthConnect Remote Viewing, Planning and Collaboration SystemHAW2017-04-21 Ver
510(k) K162309 StealthStation S8 System Platforms and StealthStation Cranial SoftwareHAW2017-03-31 Ver
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