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

QYX 2026-04-21

RhythmStar System (SL)

Applicant RhythMedix, LLC

K-Number K250793

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MBI 2026-04-21

Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line

Applicant Tigon Medical

K-Number K260921

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LZH 2026-04-20

Luminoah FLOW™ Enteral Nutrition System

Applicant Luminoah

K-Number K253558

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OVE 2026-04-20

SAGI Cervical Cage System

Applicant ZheJiang Decans Medical Devices Co., Ltd.

K-Number K253213

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ITI 2026-04-20

Power Wheelchair (N5919 series)

Applicant Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

K-Number K253806

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KGI 2026-04-20

Lunar Astra

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K-Number K252718

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GEX 2026-04-20

Q-Switched Nd: YAG Laser System (Glamor Q)

Applicant Nanjing Bestview Laser S&T Co., Ltd.

K-Number K260153

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OWN 2026-04-20

SmartSurgN Visualization System

Applicant SmartsurgN, Inc.

K-Number K242163

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QIH 2026-04-20

Folliscan

Applicant Mim Fertility

K-Number K252332

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SDO 2026-04-20

xStep (xStep)

Applicant Spinex, Inc.

K-Number K253638

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FYA 2026-04-20

Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)

Applicant Hubei Xinxin Non-Woven Co., Ltd.

K-Number K253003

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DQK 2026-04-20

EnSite™ X EP System

Applicant ABBOTT MEDICAL

K-Number K260212

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