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

KPS 2026-09-11

MICSI-PET

Applicant Microstructure Imaging, Inc.

K-Number K261305

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N/A 2026-09-11

DRIM-Nail System

Applicant 41Medical AG

K-Number K260115

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KRA 2026-09-11

Extroducer Infusion Catheter System

Applicant SmartWise Sweden AB

K-Number K254051

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OBO 2026-09-11

ANTERION

Applicant Heidelberg Engineering GmbH

K-Number K261019

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QFG 2026-09-11

Mint ACE Pump

Applicant Beta Bionics, Inc.

K-Number K260001

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FPA 2026-09-11

Ecomed Disposable Administration Sets

Applicant Ecomed Solutions, LLC

K-Number K254123

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OMP 2026-09-11

RENASYS DYNAFLOW Kit (66807741)

Applicant Smith & Nephew Medical, Ltd.

K-Number K261338

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NFO 2026-09-11

PureLift Pro Max

Applicant Xtreem Pulse, LLC

K-Number K262861

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MWJ 2026-09-11

Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)

Applicant Shenzhen Xinyan Medical Technology Co.,ltd.

K-Number K254119

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HBF 2026-09-11

Disposable Sterile Skull Drill (LZ)

Applicant Guizhou Zirui Technology Co., Ltd.

K-Number K254177

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MYC 2026-09-11

KOWA FM-600

Applicant Kowa Company, Ltd. Chofu Factory

K-Number K261255

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HBC 2026-09-11

Surgical Power System

Applicant Guizhou Zirui Technology Co., Ltd.

K-Number K254174

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