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

DZE 2025-07-23

SD TL Implant System

Applicant Arum Dentistry Co., Ltd.

K-Number K250280

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LLZ 2025-07-23

Neuro Insight V1.0

Applicant Olea Medical S.A.S.

K-Number K243681

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OLO 2025-07-23

Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)

Applicant Innovasis, Inc.

K-Number K251073

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ESW 2025-07-23

Resilience Fully Covered Esophageal Stent System

Applicant Merit Medical Systems, Inc.

K-Number K251265

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MQF 2025-07-23

Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)

Applicant Vitrolife Sweden AB

K-Number K243373

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DZE 2025-07-23

DESS® Dental Implants

Applicant Terrats Medical SL

K-Number K251280

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NAY 2025-07-23

Da Vinci Surgical System (IS5000)

Applicant Intuitive Surgical, Inc.

K-Number K251213

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LLZ 2025-07-23

IMAGE ONE

Applicant Infomed Software, S.L.

K-Number K250716

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NEU 2025-07-23

MammoSTAR Biopsy Site Identifier

Applicant Carbon Medical Technologies, Inc.

K-Number K251748

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DQK 2025-07-23

HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)

Applicant Edwards Lifesciences

K-Number K243781

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PBP 2025-07-22

Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)

Applicant Minnesota Medical Technologies

K-Number K243367

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LLZ 2025-07-22

GyriCalc (Version 1.0.0)

Applicant Neurospectrum Insights Corp.

K-Number K250686

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