Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

GXI 2026-02-13

STAR RF Ablation System

Applicant Merit Medical Systems, Inc.

K-Number K251802

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DXN 2026-02-13

Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)

Applicant Joytech Healthcare Co. , Ltd.

K-Number K252685

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HGX 2026-02-13

Wearable Breast Pump (Model W2)

Applicant Shenzhen TPH Technology Co., Ltd.

K-Number K252422

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OWN 2026-02-13

cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)

Applicant VPIX Medical, Inc.

K-Number K251852

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LIT 2026-02-13

Armada 14 NC PTA Catheter

Applicant ABBOTT MEDICAL

K-Number K252512

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CBI 2026-02-13

Chartis Precision Catheter

Applicant Pulmonx Corporation

K-Number K253096

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OLX 2026-02-13

PreOp v3

Applicant Clouds of Care

K-Number K252565

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OCW 2026-02-13

Endomina EZFuse system

Applicant Endo Tools Therapeutics S.A.

K-Number K252400

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DXN 2026-02-13

Wearable Ambulatory Blood Pressure Monitor (WBP-02A)

Applicant Shenzhen Hingmed Medical Instrument Co., Ltd.

K-Number K251581

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MOF 2026-02-13

Willow 18 Guidewire

Applicant Arbor Endovascular, LLC

K-Number K260130

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QOF 2026-02-13

VELO Respiratory Test

Applicant Lex Diagnostics Limited

K-Number K251742

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OLI 2026-02-13

Contour Light (CL-100)

Applicant Contour Research, LLC

K-Number K243854

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