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

JAK 2025-08-28

CT:VQ

Applicant 4Dmedical Limited

K-Number K251484

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NUH 2025-08-28

OTC 4-Channel Rechargeable TENS Unit

Applicant Changsha Anxiang Medical Technology Co., Ltd.

K-Number K251429

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KWQ 2025-08-28

Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)

Applicant Alphatec Spine, Inc.

K-Number K251965

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PHX 2025-08-28

JARVIS Glenoid Reverse Shoulder Prosthesis

Applicant FH Industrie

K-Number K252411

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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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