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

MBI 2026-07-29

Suture Button Repair System

Applicant Skeletal Dynamics, Inc.

K-Number K261770

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GWO 2026-07-29

CraniUS Plate

Applicant CraniUS, LLC

K-Number K261058

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DYB 2026-07-29

NAMIC Dilator and Sheath

Applicant Medline Industries, LP

K-Number K253526

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FMI 2026-07-29

Profoject™ Dual-Safety Pen Needles

Applicant CMT Health PTE., Ltd.

K-Number K261829

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OLR 2026-07-29

Emanate Tray

Applicant Emanate Biomedical

K-Number K251908

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LLZ 2026-07-29

Cleerly LABS

Applicant Cleerly, Inc.

K-Number K260588

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DQY 2026-07-29

CPS Locator 3D Plus Delivery Catheter

Applicant CenterPoint Systems, LLC

K-Number K261766

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DQY 2026-07-29

SSPC NXT Delivery Catheter

Applicant CenterPoint Systems, LLC

K-Number K262240

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QIH 2026-07-29

Cleerly Plaque

Applicant Cleerly, Inc.

K-Number K261210

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MAX 2026-07-28

TruLift Expandable System

Applicant Life Spine, Inc.

K-Number K261430

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FMZ 2026-07-28

Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)

Applicant Datex-Ohmeda, Inc.

K-Number K260326

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IYN 2026-07-28

V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;

Applicant Samsung Medison Co., Ltd.

K-Number K261412

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