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

SBF 2025-10-03

xvision Spine system

Applicant Augmedics, Ltd.

K-Number K251639

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PDJ 2025-10-03

Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01

Applicant Tosoh Bioscience, Inc.

K-Number K250073

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QNP 2025-10-03

MAGENTIQ-COLO (ME-APDS)

Applicant Magentiq Eye, Ltd.

K-Number K252178

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OMP 2025-10-03

extriCARE® 1000 Negative Pressure Wound Therapy System

Applicant Alleva Medical Devices

K-Number K251646

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ODG 2025-10-03

EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)

Applicant Olympus Medical Systems Corporation

K-Number K251859

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GEX 2025-10-03

TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)

Applicant Jeisys Medical Incorporated

K-Number K251464

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LRK 2025-10-03

Anti Snore Mouthpiece

Applicant Dongguan Yiyao Science & Technology Development Co., Ltd.

K-Number K250028

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GEX 2025-10-03

HESTIA (L200-A)

Applicant Senbitec Co., Ltd.

K-Number K242946

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DQX 2025-10-03

Amplatzer Guidewire

Applicant ABBOTT MEDICAL

K-Number K250031

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IOR 2025-10-03

Manual Wheelchair (SYIV100A008)

Applicant Ningbo Shenyu Medical Equipment Co.,Ltd

K-Number K252517

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EZD 2025-10-03

Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)

Applicant Hollister Incorporated

K-Number K251468

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PKC 2025-10-03

AETOS Shoulder System Stemless Humeral Prosthesis

Applicant Smith & Nephew, Inc.

K-Number K252129

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