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

NXC 2025-08-27

Additively Manufactured Aligner Resin

Applicant Aidite (Qinhuangdao) Technology Co., Ltd.

K-Number K251415

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OCT 2025-08-27

KnoxFog Anti-fogging Device

Applicant Uv One Hygienics, Inc.

K-Number K251068

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EOQ 2025-08-27

Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)

Applicant Shanghai AnQing Medical Instrument Co., Ltd.

K-Number K251752

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QOF 2025-08-27

QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini

Applicant QIAGEN GmbH

K-Number K250080

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DXF 2025-08-27

HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)

Applicant Atraverse Medical, Inc.

K-Number K252419

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CAW 2025-08-27

Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))

Applicant Nanjing Yinuoji Medical Technology Co., Ltd.

K-Number K250625

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HRX 2025-08-27

ELID (Endoscopic Less Invasive Decompression) System

Applicant Lesspine Innovations

K-Number K243774

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HWC 2025-08-27

Phoenix Sinus Tarsi Stent System

Applicant Astra Orthomed, Inc.

K-Number K251382

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MQL 2025-08-27

Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])

Applicant Donnevie Medical Technology (Shanghai) Co. , Ltd.

K-Number K251637

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MWI 2025-08-27

QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)

Applicant Fysicon BV

K-Number K241766

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QIH 2025-08-27

VistaSoft 4.0 and VisionX 4.0

Applicant Durr Dental SE

K-Number K250947

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HGM 2025-08-27

Fetal & Maternal Monitor (F15A, F15A Air)

Applicant Edan Instruments, Inc.

K-Number K241882

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