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

OLO 2026-06-26

VERTICALE® Navigation Instruments

Applicant Silony Medical GmbH

K-Number K253921

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SAN 2026-06-26

PhAST instrument and PhAST Blood Culture Gram-negative Panel

Applicant Phast Corp.

K-Number K253316

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CGL 2026-06-26

i-STAT Crea cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K261039

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DXF 2026-06-26

LightningWire Transseptal Puncture System (TPS)

Applicant ElectroWire Medical

K-Number K261745

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DQO 2026-06-26

Arterial Pressure Monitoring Set/Tray

Applicant Spectrum Vascular

K-Number K261455

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MBI 2026-06-26

Arthrex FiberButton

Applicant Arthrex, Inc.

K-Number K260018

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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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