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

JKA 2026-09-25

Profoject™ Safety Sliding Blood Collection Set

Applicant CMT Health PTE., Ltd.

K-Number K262215

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GDW 2026-09-25

easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges

Applicant Ezisurg Medical Co., Ltd.

K-Number K254291

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DRT 2026-09-25

DistaSense(TM) (v1)

Applicant Life Detection Technologies

K-Number K254058

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QZF 2026-09-25

CapsoView (CVV); CapsoCloud (CLD)

Applicant CapsoVision, Inc.

K-Number K254230

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IYN 2026-09-25

EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Applicant Philips Ultrasound, LLC

K-Number K262548

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SBQ 2026-09-25

Tempus ECG-MR

Applicant Tempus AI, Inc.

K-Number K254297

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PNN 2026-09-25

Invisalign System

Applicant Align Technology, Inc.

K-Number K262196

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DPS 2026-09-25

S-Patch CardioAI

Applicant Wellysis Corp.

K-Number K254255

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PHZ 2026-09-25

Aevice Wheeze Detection Module

Applicant Aevice Health Pte. , Ltd.

K-Number K260140

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SHW 2026-09-25

TumorSight Risk

Applicant SimBioSys, Inc.

K-Number K260023

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OHT 2026-09-25

Braun Aura 9 (6042)

Applicant Cyden Limited

K-Number K261977

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CAZ 2026-09-25

Profoject™ LOR Syringe

Applicant CMT Health PTE., Ltd.

K-Number K261372

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