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

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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KCT 2025-07-22

Guided DAS Surgical Kit

Applicant Talladium España, SL

K-Number K243425

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KCT 2025-07-22

Plastic Surgical Kits

Applicant Dentsply Sirona, Inc.

K-Number K251300

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NXC 2025-07-22

Clear Miracle

Applicant Ods Co., Ltd.

K-Number K251616

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INI 2025-07-22

Mobility Scooter (MS160C)

Applicant Suzhou Master Machinery Manufacturing Co.,Ltd

K-Number K251638

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LNH 2025-07-22

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K250901

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FRO 2025-07-22

Granudacyn® Wound Irrigation Solution

Applicant P.G.F. Industry Solutions GmbH

K-Number K243415

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MQB 2025-07-22

Yushan X-Ray Flat Panel Detector

Applicant Innocare Optoelectronics Corp.

K-Number K250211

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MBI 2025-07-22

OTS 25-L (100-5)

Applicant Ots Medical , Ltd.

K-Number K251310

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