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

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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FRO 2025-08-27

Dermalage

Applicant Infection Elimination Solutions, LLC

K-Number K243166

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QME 2025-08-27

Vital Signs

Applicant Oxehealth Limited

K-Number K243687

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LZA 2025-08-27

Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate

Applicant Basic Medical Technology, Inc.

K-Number K251716

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NFT 2025-08-27

CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup

Applicant Hangzhou Clongene Biotech Co., Ltd.

K-Number K252118

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MQL 2025-08-26

Ultra-Fast Vitri; Ultra-Fast Warm

Applicant Kitazato Corporation

K-Number K251305

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GEX 2025-08-26

Heager Medical Laser Family (Sabrina/Adolf)

Applicant Heager GmbH

K-Number K250261

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MOF 2025-08-26

X-Wire Guidewire

Applicant Imperative Care, Inc.

K-Number K244061

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FGB 2025-08-26

Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000)

Applicant Seplou (Zhuhai) Co., Ltd.

K-Number K250049

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