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

DXQ 2025-09-03

AViTA Arm Type Blood Pressure Monitor Cuff

Applicant Avita Corporation

K-Number K250765

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HSN 2025-09-03

Kinos Total Ankle System

Applicant Restor3D

K-Number K252454

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DXN 2025-09-03

Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856)

Applicant Dongguan E-Test Technology Co., Ltd.

K-Number K250231

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EIH 2025-09-03

BruxZir® NOW

Applicant Prismatik Dentalcraft, Inc.

K-Number K252446

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SAO 2025-09-02

OsteoSight™ Hip (v1)

Applicant Naitive Technologies, Ltd.

K-Number K251408

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MYN 2025-09-02

VELMENI for DENTISTS (V4D)

Applicant Velmeni, Inc.

K-Number K250753

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NJD 2025-09-02

Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component

Applicant Ignite Orthomotion

K-Number K251975

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EMA 2025-09-02

RODIN Cement

Applicant Belport Company, Inc., Gingi-Pak

K-Number K251775

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MHX 2025-09-02

IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)

Applicant Philips Medizin Systeme Böblingen GmbH

K-Number K250453

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NHA 2025-09-02

Customized Abutment and Screw

Applicant Chengdu Besmile Medical Technology Co., Ltd.

K-Number K242768

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SFP 2025-09-02

Aerogen Pro-X1 Controller System

Applicant Aerogen, Ltd.

K-Number K251615

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LPH 2025-08-29

ArTT Augments and Buttresses and Bone Screws

Applicant Lima Corporate S.P.A.

K-Number K251718

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