Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

FMI 2025-04-03

SureFine Pen Needle

Applicant Shina Med Corporation

K-Number K250658

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QLY 2025-04-03

StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)

Applicant Staclear, Inc.

K-Number K243936

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HQF 2025-04-03

Leos Laser and Endoscopy System

Applicant Beaver-Visitec International, Inc.

K-Number K240615

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ITI 2025-04-03

Powered wheelchair (mobility robot) (M4, M4U)

Applicant Xsto Co., Ltd.

K-Number K242358

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OLO 2025-04-03

Salvo® Robotic Navigation Instruments

Applicant Spine Wave, Inc.

K-Number K243514

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MAI 2025-04-03

OSSIOfiber® Suture Anchor 2.5-3.5 mm

Applicant OSSIO , Ltd.

K-Number K243760

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KDJ 2025-04-03

staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K250404

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FET 2025-04-02

VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA

Applicant Olympus Corporations of the Americas

K-Number K242067

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FRN 2025-04-02

Plum Duo Precision IV Pump

Applicant Icu Medical, Inc.

K-Number K242115

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QNQ 2025-04-02

Small Volume 0.2mL Syringe

Applicant Prosum Medical Limited

K-Number K250138

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JXI 2025-04-02

Nerve Wrap (07-DW-001-TAB)

Applicant Biocircuit Technologies, Inc.

K-Number K242113

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HGX 2025-04-02

eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060;

Applicant Shenzhen TPH Technology Co., Ltd.

K-Number K250152

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