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

FDS 2025-10-10

EvoEndo Single-Use Endoscopy System

Applicant EvoEndo, Inc.

K-Number K251708

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QXQ 2025-10-10

SoClean 3+

Applicant Soclean, Inc.

K-Number K243815

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KNS 2025-10-10

Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)

Applicant Olympus Medical Systems Corporation

K-Number K250351

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GMQ 2025-10-10

Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System

Applicant Gold Standard Diagnostics, LLC

K-Number K250249

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KGN 2025-10-10

Collagen Wound Dressing

Applicant Winner Medical Co., Ltd.

K-Number K252001

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SGE 2025-10-10

Zeta Navigation System (ZNS131-US)

Applicant Zeta Surgical, Inc.

K-Number K251927

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NBW 2025-10-10

On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System

Applicant ACON Laboratories, Inc.

K-Number K250085

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OLO 2025-10-10

TMINI Miniature Robotic System

Applicant THINK Surgical, Inc.

K-Number K252544

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PLV 2025-10-10

Yomi Robotic System

Applicant Neocis, Inc.

K-Number K251835

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OHT 2025-10-10

IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)

Applicant Foshan Jindi Electric Appliance Co., Ltd.

K-Number K252209

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OWB 2025-10-10

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging

Applicant Canon Medical Systems Corporation

K-Number K251602

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PZP 2025-10-10

HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)

Applicant Procept Biorobotics

K-Number K251082

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