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

KNS 2025-09-29

SureTome™ SW Sphincterotome with DomeTip

Applicant Wilson-Cook Medical

K-Number K251104

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SBG 2025-09-29

allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)

Applicant Tulavi Therapeutics, Inc.

K-Number K252051

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DZE 2025-09-29

Paltop Dental Implant System

Applicant Paltop Advanced Dental Solutions, Ltd.

K-Number K243983

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HRX 2025-09-29

UltraGuideCTR® image guided soft tissue release system

Applicant Sonex Health

K-Number K252594

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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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