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

LNH 2026-09-16

Embrace Vision Neonatal MRI System

Applicant Aspect Imaging, Ltd.

K-Number K261758

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IYE 2026-09-16

AerFrame™ Alignment Laser Box (LBV2)

Applicant Stabilix, LLC

K-Number K261865

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MSB 2026-09-16

X°Port Heart Preservation System

Applicant Traferox Technologies, Inc.

K-Number K261913

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QJP 2026-09-16

Route 92 Medical Full Length 046 Access System

Applicant Route 92 Medical, Inc.

K-Number K260220

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QIH 2026-09-16

EchoPAC Software Only / EchoPAC Plug-in (v211)

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K261623

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HAE 2026-09-15

Tontarra Punches and Rongeurs

Applicant Tontarra Medizintechnik GmbH

K-Number K260446

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FGB 2026-09-15

CVAC® Aspiration System

Applicant Calyxo, Inc.

K-Number K261447

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IOR 2026-09-15

Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)

Applicant Zhenjiang Assure Medical Equipment Co., Ltd.

K-Number K260141

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LLZ 2026-09-15

OOOPDS

Applicant Taiwan Main Orthopaedic Biotechnology Co., Ltd.

K-Number K254214

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IOR 2026-09-15

YJ-K1K2 Wheelchair (YJ-013F)

Applicant Zhenjiang Assure Medical Equipment Co., Ltd.

K-Number K260145

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HRS 2026-09-15

TMC Implant Fixation System

Applicant Treace Medical Concepts, Inc.

K-Number K262963

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GEI 2026-09-15

LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated

Applicant Covidien, LLC

K-Number K261070

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