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

NUC 2026-07-06

Plum Vagiceuticals™ Vaginal Moisturizing Suppositories

Applicant PCCA, Inc.

K-Number K261909

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QRL 2026-07-06

Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)

Applicant SteriLance Medical (Suzhou), Inc.

K-Number K260122

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LLZ 2026-07-06

INDIRA CLOUD VIEWER

Applicant INDIGO TECHNOLOGIES

K-Number K261465

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LYC 2026-07-06

Cytrans™ Elashield

Applicant GC America, Inc.

K-Number K253317

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DYB 2026-07-06

Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)

Applicant Hartman Medical Group, LLC

K-Number K261529

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LZO 2026-07-06

MobileLink Acetabular Cup System – 40mm ID Inserts (various)

Applicant Waldemar Link GmbH & Co. KG

K-Number K261009

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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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