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

LBH 2026-04-30

UltraEZ

Applicant Ultradent Products, Inc.

K-Number K261404

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BYI 2026-04-30

AffloVest® Mobile Airway Clearance Therapy

Applicant Tactile Medical

K-Number K252849

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NKB 2026-04-29

LEO Spinal System

Applicant ZheJiang Decans Medical Devices Co., Ltd.

K-Number K252542

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DYB 2026-04-29

Echo Large Bore Introducer Sheath

Applicant Echo Medical, LLC

K-Number K260606

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GEX 2026-04-29

YellowStar

Applicant Asclepion Laser Technologies GmbH

K-Number K261094

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QIH 2026-04-29

syngo Application Software

Applicant Siemens Medical Solutions USA, Inc.

K-Number K254184

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QXQ 2026-04-29

Paptizer 360

Applicant LiViliti Health Products Corporation

K-Number K252471

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LNS 2026-04-29

Break Wave

Applicant Sonomotion, Inc.

K-Number K261086

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MOF 2026-04-29

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire

Applicant Scientia Vascular, Inc.

K-Number K253579

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BZD 2026-04-29

F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)

Applicant BMC Medical Co., Ltd.

K-Number K253166

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LPL 2026-04-29

PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES

Applicant GEO MEDICAL CO., LTD.

K-Number K253885

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IYN 2026-04-29

ES-Series

Applicant E-Scopics

K-Number K260589

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