Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

QYT 2025-10-12

COVID-19 Detect Rapid Self -Test

Applicant InBios International, Inc.

K-Number K251595

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PAY 2025-10-12

GENEO X ELITE

Applicant Pollogen, Ltd.

K-Number K242227

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GEH 2025-10-10

Verruca-Freeze H Plus

Applicant Cryosurgery, Inc.

K-Number K252903

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HWC 2025-10-10

Eleganz IM Threaded Nail System (IM Threaded Nail System)

Applicant Dev4

K-Number K252312

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ODP 2025-10-10

DeGen Medical Latitude-C AM Cervical Interbody Fusion System

Applicant Degen Medical

K-Number K252737

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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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