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

DHB 2026-07-21

NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut

Applicant Hycor Biomedical

K-Number K260591

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LLZ 2026-07-21

ResolutionMD

Applicant ResolutionMD, Inc.

K-Number K260500

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LZA 2026-07-21

PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves

Applicant O&M Halyard, Inc.

K-Number K262014

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GEX 2026-07-21

Medical Thulium Fiber Laser Systems (UroFiber 150Q)

Applicant Rhein Laser Technologies Co., Ltd.

K-Number K261738

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N/A 2026-07-21

Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)

Applicant Xuzhou Kernel Medical Equipment Co., Ltd.

K-Number K261775

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HBO 2026-07-21

Raney Clips Kit

Applicant Beijing Honghugaoxiang Science and Technology Development CO

K-Number K253814

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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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