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

ITI 2025-09-09

Electric Wheelchair (GY-E001)

Applicant Shandong Guyue Healthcare Appliance Co., Ltd.

K-Number K251891

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KPO 2025-09-09

Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K252180

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QIH 2025-09-09

Segmentron Viewer

Applicant DGNCT, LLC

K-Number K251072

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KPS 2025-09-09

Hybrid Viewer (00859873006240)

Applicant Hermes Medical Solutions AB

K-Number K252477

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LNH 2025-09-09

MuscleView 2.0

Applicant Springbok, Inc. (Dba Springbok Analytics)

K-Number K251682

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ONN 2025-09-09

Quadsense (Quadsense and Quadsense Pro)

Applicant Eventum Orthopaedics, Ltd.

K-Number K252524

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GEI 2025-09-09

PhotonBlade 3; PhotonBlade 3 Smoke Evacuation

Applicant Stryker Instruments

K-Number K250483

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FIP 2025-09-09

AquaA

Applicant Fresenius Medical Care North America

K-Number K252181

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QTZ 2025-09-08

BioTraceIO Vision (V1.7)

Applicant Techsomed Medical Technologies

K-Number K251931

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QJP 2025-09-08

DUO Microcatheter

Applicant Rev Neuro, LLC

K-Number K250960

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NAY 2025-09-08

da Vinci Surgical System (IS5000)

Applicant Intuitive Surgical, Inc.

K-Number K251227

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QAS 2025-09-08

qER-CTA (v1.0)

Applicant Qure.Ai Technologies

K-Number K251610

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