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

JAK 2026-07-21

CardIQ Suite

Applicant GE Medical Systems SCS

K-Number K253770

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EJK 2026-07-21

One-Fil LC

Applicant Mediclus Co., Ltd.

K-Number K261728

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HRS 2026-07-21

Versalock Proximal Tibial Plating System

Applicant GM Dos Reis Industria e Comercio Ltda.

K-Number K261406

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QIH 2026-07-20

Hi-D Imaging 4TAVR

Applicant Hi-D Imaging AG

K-Number K261535

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QZW 2026-07-20

Sleep Apnea Feature (v2.0)

Applicant Samsung Electronics Co., Ltd.

K-Number K261011

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LZA 2026-07-20

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue

Applicant Hartalega NGC Sdn. Bhd.

K-Number K254285

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FGB 2026-07-20

BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)

Applicant MacroLux Medical Technology Co., Ltd.

K-Number K260516

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MBI 2026-07-20

Thunderbolt System

Applicant Responsive Arthroscopy, Inc.

K-Number K261632

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QZB 2026-07-20

ENDOSCOPE HOLDER (182214)

Applicant Aktormed GmbH

K-Number K261573

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FZP 2026-07-20

Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating Clips

Applicant Taiwan Surgical Corporation

K-Number K254231

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MOF 2026-07-17

Drivewire 35 Guidewire

Applicant Rapid Medical Ltd.

K-Number K254006

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PMN 2026-07-17

BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit

Applicant Biofire Defense, LLC

K-Number K261475

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