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

PQA 2026-07-16

cobas® BV/CV

Applicant Roche Molecular Systems, Inc.

K-Number K260021

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QIH 2026-07-15

SkeletonPlanner

Applicant UPlanner B.V. - Presurgeo

K-Number K260206

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MNR 2026-07-15

WRAP System

Applicant Huneo, LLC

K-Number K260050

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QJU 2026-07-15

ThinkSono Guidance

Applicant ThinkSono GmbH

K-Number K260338

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QEZ 2026-07-15

Aventus Thrombectomy System

Applicant Inquis Medical

K-Number K262030

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FMI 2026-07-15

Profoject™ Pen Needles (Model A; Model B)

Applicant CMT Health PTE., Ltd.

K-Number K260739

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PLR 2026-07-15

Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant

Applicant Atlas Spine, Inc.

K-Number K252822

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MYN 2026-07-15

Better Diagnostics Dental Assist (BDDA) Version 1.0

Applicant Better Diagnostics AI Corp.

K-Number K260851

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OHS 2026-07-15

XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)

Applicant Dongguan Miqiang Technology Co., Ltd.

K-Number K261407

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OVD 2026-07-15

Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System

Applicant Kyocera Medical Technologies, Inc.

K-Number K261353

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DQK 2026-07-15

EnSite™ X EP System

Applicant Abbott Medical

K-Number K262006

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PSY 2026-07-15

NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system

Applicant Hamamatsu Photonics K.K.

K-Number K253606

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