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

GEI 2025-06-19

Electrosurgical Pads

Applicant Baisheng Medical Co., Ltd.

K-Number K251235

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POS 2025-06-19

EpiMonitor

Applicant Empatica S.r.l.

K-Number K250515

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OAT 2025-06-19

Leone Orthodontic Implant TAD (Temporary Anchorage Device)

Applicant Leone S.P.A.

K-Number K242944

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OLO 2025-06-18

SPINEART Navigation Instrument System

Applicant Spineart SA

K-Number K242933

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PIF 2025-06-18

Enteral Drainage System, Enteral Medicine straw

Applicant HMC Premedical S.p.A.

K-Number K242917

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MBI 2025-06-18

CONMED Argo Knotless® Anchor

Applicant Conmed Corporation

K-Number K251530

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MNR 2025-06-18

Happy Health Home Sleep Test

Applicant Happy Health, Inc.

K-Number K242224

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LJT 2025-06-18

PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port

Applicant Bard Access Systems, Inc.

K-Number K251253

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BZD 2025-06-18

F&P Nova Nasal Mask

Applicant Fisher & Paykel Healthcare Limited

K-Number K243583

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HRS 2025-06-18

The Acumed Wrist Fixation System

Applicant Acumed, LLC

K-Number K251296

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IYN 2025-06-18

6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)

Applicant Esaote, S.p.A.

K-Number K243253

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FXX 2025-06-18

Procedure mask/Surgical mask/Face mask

Applicant Winner Medical Co., Ltd.

K-Number K250082

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