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

OHT 2026-04-21

IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)

Applicant Shenzhen Semlamp Intelligent Technology Co., Ltd.

K-Number K260518

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NKB 2026-04-21

CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K260216

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QJP 2026-04-21

BosCATH Support Catheter

Applicant Sonorous NV, Inc.

K-Number K254046

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FDS 2026-04-21

EvoEndo Single-Use Endoscopy System

Applicant EvoEndo, Inc.

K-Number K260573

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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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