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

SCR 2025-09-26

Tuned Self-Fitting Mobile App

Applicant Tuned , Ltd.

K-Number K251208

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QIH 2025-09-26

Ligence Heart

Applicant Ligence Uab

K-Number K252105

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PHX 2025-09-26

Inset Reverse Total Shoulder System

Applicant Shoulder Innovations, Inc.

K-Number K252221

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OCX 2025-09-26

AUXILIARY WATER TUBE MAJ-855

Applicant Olympus Medical Systems Corporation

K-Number K251986

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SFV 2025-09-26

Planmed XFI

Applicant Planmed OY

K-Number K250318

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JAK 2025-09-26

Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP

Applicant Canon Medical Systems Corporation

K-Number K251645

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BZQ 2025-09-26

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)

Applicant Linshom Medical, Inc.

K-Number K250093

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PNL 2025-09-26

Magnetic Surgical System

Applicant Levita Magnetics International Corp

K-Number K252435

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GEX 2025-09-26

Thulium Laser System (Deluxlase)

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

K-Number K251919

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EZD 2025-09-26

LoFric Origo

Applicant Wellspect AB

K-Number K250659

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BWH 2025-09-26

Radial Jaw 4 Pulmonary Biopsy Forceps

Applicant Boston Scientific Corporation

K-Number K252921

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DZE 2025-09-26

S.I.N. Dental Implant System

Applicant S.I.N. Implant System Ltda

K-Number K251262

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