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

GEX 2025-12-24

PICO-K

Applicant Speclipse, Inc.

K-Number K253342

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OHS 2025-12-24

Feather/numiere 05 06 07 (05)

Applicant Heat IN A Click, LLC

K-Number K253279

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OHS 2025-12-24

LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)

Applicant Shenzhen Saidi Light Therapy Technology Co., Ltd.

K-Number K253400

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OAP 2025-12-24

Hair Regrowth Cap (Model: T-119-HRC)

Applicant Light Tree Ventures Europe B.V.

K-Number K253349

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OBO 2025-12-23

UNITY DX (UDX)

Applicant Cylite Pty. , Ltd.

K-Number K252633

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LNH 2025-12-23

AIR Recon DL

Applicant Ge Medical Systems, LLC

K-Number K252379

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NFO 2025-12-23

Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)

Applicant Shenzhen Siken 3D Technology Development Co., Ltd.

K-Number K252146

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JOJ 2025-12-23

SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)

Applicant Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.

K-Number K251991

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DZI 2025-12-23

VarioSurg 4

Applicant Nakanishi, Inc.

K-Number K254163

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DHB 2025-12-23

NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)

Applicant Hycor Biomedical

K-Number K252493

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MBH 2025-12-23

Active-V Total Knee System; World Total Knee System

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K253239

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HRX 2025-12-23

MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)

Applicant Medimaging Integrated Solution, Inc (Miis)

K-Number K253217

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