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

N/A 2026-06-26

BioTracker 2.0

Applicant Biotracker, LLC

K-Number K253306

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HRS 2026-06-26

SALGINA 2.5mm Distal Radius System

Applicant Bonebridge AG

K-Number K261351

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JOW 2026-06-25

DVT Garment

Applicant Vistar Medical Supplies Co., Ltd.

K-Number K253386

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QUH 2026-06-25

Jabra Enhance Select Self-fit (Jabra Enhance Select 550)

Applicant GN Hearing A/S

K-Number K254108

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LLZ 2026-06-25

MiPACS V5 (1.0.0)

Applicant Apryse Software Corp

K-Number K260231

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MWJ 2026-06-25

mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)

Applicant Seers Technology Co., Ltd.

K-Number K253384

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DYB 2026-06-25

SimplGuide

Applicant Pendracare

K-Number K261242

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HIF 2026-06-25

Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)

Applicant Weyo Surgical Technology , Ltd.

K-Number K252584

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BSZ 2026-06-25

A5 Anesthesia System (A5); A7 Anesthesia System (A7)

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

K-Number K253330

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HGX 2026-06-25

Wearable breast pump (QY-101, QY-102, QY-108)

Applicant Shenzhen Qinyi Electronic Technology Co., Ltd.

K-Number K261025

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GXN 2026-06-25

ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)

Applicant Longeviti Neuro Solutions

K-Number K260709

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BZQ 2026-06-25

BedDot (G1)

Applicant Intelligent Dots, LLC

K-Number K253274

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