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

KLE 2026-05-14

Any-Etch

Applicant Mediclus Co., Ltd.

K-Number K260485

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IZL 2026-05-14

RAYMO Mobile X-ray System (Model: RAYMO)

Applicant DRGEM Corporation

K-Number K260085

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QAS 2026-05-14

BriefCase-Triage

Applicant Aidoc Medical , Ltd.

K-Number K261317

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NHA 2026-05-14

ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments

Applicant Hiossen, Inc.

K-Number K253372

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KGN 2026-05-14

MatriDerm

Applicant Medskin Solutions Dr. Suwelack AG

K-Number K261224

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LLZ 2026-05-14

SubtleHD-PET (1.x)

Applicant Subtle Medical, Inc.

K-Number K254013

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EOB 2026-05-14

ENTity USB Videoscope System

Applicant Optim, LLC

K-Number K254133

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KPI 2026-05-14

Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)

Applicant Hunan Accurate Bio-Medical Technology Co., Ltd.

K-Number K252601

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DXN 2026-05-14

Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)

Applicant Shenzhen Urion Technology Co., Ltd.

K-Number K254048

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MUJ 2026-05-14

ART.1-US

Applicant Seetreat Pty, Ltd.

K-Number K253078

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KWQ 2026-05-14

ARIES Anterior Cervical Plate Systems

Applicant ZheJiang Decans Medical Devices Co., Ltd.

K-Number K252776

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BTA 2026-05-14

Suction Pump (SU-90)

Applicant Shenzhen HugeMed Medical Technical Development Co., Ltd.

K-Number K260892

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