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

HGX 2026-06-26

Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)

Applicant Shenzhen Changkun Technology Co., Ltd.

K-Number K250070

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GXY 2026-06-26

Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array

Applicant Cadwell Industries, Inc.

K-Number K261442

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OAP 2026-06-26

Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)

Applicant Ziree Co., Ltd.

K-Number K261253

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NUH 2026-06-26

TENS 7000 Rechargeable 4 Channel (TENS 7000H)

Applicant Shenzhen Dongdixin Technology Co., Ltd.

K-Number K260412

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PZX 2026-06-26

ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)

Applicant Edwards Lifesciences

K-Number K254232

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QDQ 2026-06-26

MammoScreen® (5)

Applicant Therapixel

K-Number K260714

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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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