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

QIH 2026-01-29

Neurophet AQUA AD Plus

Applicant Neurophet., Inc.

K-Number K252496

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INI 2026-01-29

Electric Scooter (Mojo-T330)

Applicant Dongguan Smarfody Mobility Technology Co., Ltd.

K-Number K252349

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OBH 2026-01-28

MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)

Applicant ImpediMed Limited

K-Number K253224

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FRG 2026-01-28

Sterilization Pouch/Roll

Applicant Sterivic Medical Co., Ltd.

K-Number K251347

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QKB 2026-01-28

Seg Pro V3 (RT-300)

Applicant Ever Fortune.Ai, Co., Ltd.

K-Number K251306

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DQK 2026-01-28

NorthStar™ Mapping System

Applicant Imricor Medical Systems

K-Number K252164

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FRN 2026-01-28

FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing

Applicant Koru Medical Systems, Inc.

K-Number K252015

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LYK 2026-01-28

Vena MicroAngioscope™ System

Applicant Vena Medical Holdings Corp

K-Number K253842

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OUR 2026-01-28

Sacroiliac Joint Truss System (SJTS)

Applicant 4Web Medical

K-Number K252834

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ELC 2026-01-28

GBT Machine Airflow Prophylaxis Master

Applicant E.M.S Electro Medical Systems S.A

K-Number K253254

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LPH 2026-01-28

Mpact 3D Metal Implants Extension – DMLS Technology

Applicant Medacta International S.A.

K-Number K251043

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IRP 2026-01-28

Hand Massager (SM004D)

Applicant Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.

K-Number K251622

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