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

OLZ 2026-03-08

Onera SleepMap (SLEEPMAP)

Applicant Onera B.V.

K-Number K253668

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QIH 2026-03-06

VELYS™ Hip Navigation

Applicant Depuy Ireland UC

K-Number K253551

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JAK 2026-03-06

Bunkerhill Contrast AVC

Applicant BunkerHill Health

K-Number K260167

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GEX 2026-03-06

Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)

Applicant Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

K-Number K253951

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JAK 2026-03-06

Bunkerhill Contrast CAC

Applicant BunkerHill Health

K-Number K260166

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FGB 2026-03-06

CVAC Image Processor

Applicant Calyxo, Inc.

K-Number K260013

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LYC 2026-03-06

BONTREE PLUS

Applicant Hudens Bio Co., Ltd.

K-Number K251818

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HIB 2026-03-06

JFord Speculum Sleeve™

Applicant Ford Medtech, LLC

K-Number K252208

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KGE 2026-03-06

Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR

Applicant Olympus Medical Systems Corp.

K-Number K251807

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DQX 2026-03-06

EmeryGlide™ (EG18008901)

Applicant Nano4imaging GmbH

K-Number K253262

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HWC 2026-03-06

Treace Medical Concepts (TMC) Screw Fixation System

Applicant Treace Medical Concepts, Inc.

K-Number K260361

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HBB 2026-03-06

Velocity Alpha MR High Speed Surgical Drill System

Applicant Adeor Medical AG

K-Number K253772

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