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

MNS 2026-03-17

BreathePal Bilevel (GFM50-MD2201)

Applicant Compal Electronics, Inc.

K-Number K252078

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GEI 2026-03-17

BTL-785NEH

Applicant BTL Industries, Inc.

K-Number K253750

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QIH 2026-03-17

EchoNavigator R5.0

Applicant Philips Medical Systems Nederland B.V.

K-Number K253614

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HRS 2026-03-17

APS Spear Locking Plate

Applicant A Plus Biotechnology Co., Ltd.

K-Number K254053

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GEX 2026-03-17

Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)

Applicant C.R. Bard, Inc.

K-Number K252971

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INI 2026-03-17

Electrical Scooter (SM4226)

Applicant Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.

K-Number K252813

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PBZ 2026-03-16

SurgiCount+ System

Applicant Stryker Instruments

K-Number K252282

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MBI 2026-03-16

SINEFIX

Applicant BAAT Medical Products B.V.

K-Number K254176

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QIH 2026-03-16

Data Analysis Facilitation Suite (DAFS)

Applicant Voronoi Health Analytics Incorporated

K-Number K253944

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DTZ 2026-03-16

Lifemotion Disposable Membrane Oxygenator

Applicant Lifemotion Medical Technology Co., Ltd.

K-Number K253838

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MOF 2026-03-16

DCwire Micro-guidewire

Applicant Shanghai Achieva Medical Suzhou Co., Ltd.

K-Number K252122

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PGW 2026-03-16

Stealth AXiS™ ENT clinical application

Applicant Medtronic Navigation, Inc.

K-Number K253395

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