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

FET 2026-07-02

FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01

Applicant Fujifilm Corporation

K-Number K261880

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FRG 2026-07-02

HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology

Applicant O&M Halyard, Inc.

K-Number K261897

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NTK 2026-07-02

iTero Lumina™ Pro

Applicant Align Technology , Ltd.

K-Number K261847

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DYH 2026-07-02

OrthoFit

Applicant Spident Co., Ltd.

K-Number K261129

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DQY 2026-07-02

Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter

Applicant Abbott

K-Number K261825

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NXC 2026-07-02

FACE4D Aligner

Applicant Avinent Implant System S.L.U.

K-Number K260527

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FDF 2026-07-02

Insufflation Retention Device (IRD) (11173-325-101)

Applicant BPEndo, LLC

K-Number K261587

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OYX 2026-07-02

Fastplex™ BCR-ABL (p210) %IS digital PCR Kit

Applicant Suzhou Precigenome, Ltd. Co;

K-Number K252243

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PIB 2026-07-02

iPredict-DR

Applicant iHealthscreen, Inc.

K-Number K253704

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POK 2026-07-02

Koios DS (3.8)

Applicant Koios Medical, Inc.

K-Number K253884

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NOT 2026-07-02

OptraSCAN System

Applicant Optrascan, Inc.

K-Number K260755

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KGN 2026-07-02

Collagen Wound Powder

Applicant Ventris Medical

K-Number K260596

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