Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

MUH 2025-11-10

EzSensor HD, EzSensor UHD

Applicant Qpix Solutions, Inc.

K-Number K252570

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PLR 2025-11-10

Atlas Spine HiRISE™ Expandable Cervical Corpectomy System

Applicant Atlas Spine, Inc.

K-Number K252560

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DPS 2025-11-10

Withings BeamO (SCT02)

Applicant Withings

K-Number K252474

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GXN 2025-11-10

KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

Applicant KLS-Martin L.P.

K-Number K252573

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NRY 2025-11-10

NeVasc Aspiration System

Applicant Vesalio, Inc.

K-Number K251006

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MHX 2025-11-10

IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )

Applicant Philips Medizin Systeme Böblingen GmbH

K-Number K251702

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SAQ 2025-11-10

Symani Surgical System

Applicant Medical Microinstruments, Inc.

K-Number K252287

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DQX 2025-11-09

Lunderquist Extra Stiff Wire Guide

Applicant William Cook Europe Aps

K-Number K251596

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DZE 2025-11-07

S.I.N. Tapered Pro Conical Zygoma Implant System

Applicant S.I.N. Implant System Ltda

K-Number K251129

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NXC 2025-11-07

Primeprint Direct Aligner

Applicant Dreve Dentamid GmbH

K-Number K250739

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QWO 2025-11-07

Fibresolve (with PCCP)

Applicant Imvaria, Inc.

K-Number K252041

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IYN 2025-11-07

Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K251853

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