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

KGN 2025-12-19

MatriDerm pluS+ Bi-Layer

Applicant Medskin Solutions Dr. Suwelack AG

K-Number K250864

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MXD 2025-12-18

Assert-IQ (DM5100)

Applicant ABBOTT MEDICAL

K-Number K253516

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FDX 2025-12-18

Single Use Cytology Brush V (BC-V600P-3010)

Applicant Olympus Medical Systems Corporation

K-Number K250993

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DQK 2025-12-18

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)

Applicant Edwards Lifesciences

K-Number K252533

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NHA 2025-12-18

SIMDA Abutments

Applicant Simda Co., Ltd.

K-Number K252320

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QIH 2025-12-18

PVAD IQ Software

Applicant Ultrasight , Ltd.

K-Number K252235

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LRK 2025-12-18

Park Dental Nylon MAD

Applicant Park Dental Research Corp.

K-Number K252976

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MXK 2025-12-18

Tomey Optical Biometer OA-2000 (OA-2000)

Applicant Tomey Corporation

K-Number K252348

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KDI 2025-12-18

FX CorAL 40; FX CorAL 50

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K253518

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PND 2025-12-18

Midline Catheter

Applicant Terumo Medical Products (Hangzhou) Co., Ltd.

K-Number K252402

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QVA 2025-12-18

RefleXion Medical Radiotherapy System, Reflexion X2

Applicant Reflexion Medical, Inc.

K-Number K252071

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QEW 2025-12-18

Helo Thrombectomy System

Applicant Endovascular Engineering, Inc.

K-Number K252956

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