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

EBF 2025-05-27

BEAUTIFIL II

Applicant Shofu Dental Corporation

K-Number K251578

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GXI 2025-05-27

Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)

Applicant ABBOTT MEDICAL

K-Number K242841

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NHA 2025-05-27

Neodent Implant System - Custom Abutments

Applicant Jjgc Indústria E Comércia DE Materiais Dentários S.A.

K-Number K250614

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MAI 2025-05-27

OSSIOfiber® Suture Anchor

Applicant OSSIO , Ltd.

K-Number K251309

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QXJ 2025-05-27

Helios+ UV-C System

Applicant Preventamed Technologies, Inc. Dba Surfacide Manufacturing

K-Number K242604

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ODD 2025-05-27

Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M

Applicant Olympus Medical Systems Corp.

K-Number K250573

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QBD 2025-05-27

Puritan PurSafe Plus Collection and Transport System

Applicant Puritan Medical Products, LLC

K-Number K242820

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DQK 2025-05-27

DeepRhythmAI

Applicant Medicalgorithmics S.A.

K-Number K250932

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SDD 2025-05-27

Dexter L6 System

Applicant Distalmotion SA

K-Number K250435

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EIA 2025-05-27

Integral Dental Units

Applicant Mipont Medical Equipment Co., Ltd.

K-Number K242611

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LBH 2025-05-27

Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3% / Cherry); Rennou Varnish (3% / Bubble Gum)

Applicant Theodent, LLC

K-Number K243777

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ITI 2025-05-27

Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3)

Applicant Ningbo Baichen Medical Devices Co., Ltd.

K-Number K250475

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