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

QCF 2026-05-13

Portable Neuromodulation Stimulator (PoNS)

Applicant Helius Medical, Inc.

K-Number K253061

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IZI 2026-05-13

SURGIMAGE SIM 1000H Fluorescence Imaging Platform

Applicant Surgimage Corporation

K-Number K253181

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DXT 2026-05-13

ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable

Applicant Acist Medical Systems, Inc.

K-Number K252653

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MBI 2026-05-13

Y-Knotless™ Flex Anchors

Applicant CONMED Corporation

K-Number K261363

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QIH 2026-05-13

Morph

Applicant BeauBrain Healthcare, Inc.

K-Number K260032

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ITI 2026-05-13

Electric Wheelchair (Y207BL)

Applicant Jiangsu Intco Medical Products Co., Ltd.

K-Number K253241

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DXT 2026-05-13

VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)

Applicant Acist Medical Systems, Inc.

K-Number K252638

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FRO 2026-05-13

StatSeal Disc

Applicant Merit Medical Systems, Inc.

K-Number K254073

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HGX 2026-05-13

Electric Breast Pump (HL-3058 II Pro)

Applicant Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.

K-Number K254125

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QAI 2026-05-13

Automatic Micro Needle System (CODE-X)

Applicant Woorhi Mechatronics Co., Ltd.

K-Number K252591

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KNW 2026-05-12

Promisemed VeriEcto Automatic Biopsy Needles

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K261196

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DZE 2026-05-12

Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant

Applicant Promimic AB

K-Number K252731

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