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

DXN 2026-01-12

Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)

Applicant Shenzhen Hingmed Medical Instrument Co., Ltd.

K-Number K251307

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FXX 2026-01-12

Disposable Surgical Face Mask (3P00B, C2900)

Applicant Beatles Medical Supplies (Xiantao) Co., Ltd.

K-Number K252830

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KIF 2026-01-12

Any-Paste

Applicant Mediclus Co., Ltd.

K-Number K253167

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EFB 2026-01-12

High speed air turbine handpiece

Applicant Foshan Topmed Dental Co., Ltd.

K-Number K251389

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LNS 2026-01-12

Break Wave

Applicant Sonomotion, Inc.

K-Number K252913

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QHE 2026-01-12

Precision AI Surgical Planning System (PAI-SPS)

Applicant Precision AI Pty, Ltd.

K-Number K251558

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GWF 2026-01-11

SafeOp 3: Neural Informatix System

Applicant Alphatec Spine, Inc.

K-Number K252842

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EIH 2026-01-09

Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series

Applicant Liaoning Upcera Co., Ltd.

K-Number K253973

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CIX 2026-01-09

Core Metabolic

Applicant Truvian Health

K-Number K251157

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PHX 2026-01-09

JARVIS Metaphyseal Stem

Applicant FH Industrie

K-Number K254003

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DQX 2026-01-09

Solo Pace Fusion System (SOLOFUSE1)

Applicant Solo Pace, Inc.

K-Number K252674

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INI 2026-01-09

Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)

Applicant Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.

K-Number K253075

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