Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

FPA 2025-10-30

BD Alaris Pump Infusion Set

Applicant Carefusion (Bd)

K-Number K250325

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IRP 2025-10-30

AIR COMPRESSION BOOTS 1018195,1018196

Applicant Merchsource, LLC

K-Number K251531

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QOF 2025-10-30

Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)

Applicant Diasorin Molecular, LLC

K-Number K252387

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QIH 2025-10-30

AiORTA - Plan

Applicant ViTAA Medical Solutions, Inc.

K-Number K250337

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OAP 2025-10-30

Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K252414

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ESW 2025-10-30

Niti-S Esophageal Stent; Esophageal TTS Stent

Applicant Taewoong Medical Co., Ltd.

K-Number K243619

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GEX 2025-10-30

Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0068130120)

Applicant Boston Scientific Corporation

K-Number K252529

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JMT 2025-10-30

AllTest Urinary Tract Infection Test

Applicant Hangzhou AllTest Biotech Co., Ltd.

K-Number K252607

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EBI 2025-10-30

Freeprint® denture flex

Applicant Detax GmbH

K-Number K252430

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QAI 2025-10-29

SER Pen Carain MicroSystem (MP1209SP)

Applicant Su-Ko Technologies, LLC

K-Number K253153

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HTN 2025-10-29

Synchfix EVT

Applicant Wright Medical Technology, Inc. (Stryker Corporation)

K-Number K251643

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KWS 2025-10-29

AETOS Shoulder System Meta Humeral Prosthesis Size 0

Applicant Smith & Nephew, Inc.

K-Number K252416

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