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

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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KGO 2026-07-28

Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Applicant Hartalega NGC Sdn. Bhd.

K-Number K260558

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KPS 2026-07-28

uMI Panvivo (uMI Panvivo M)

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K261427

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QAX 2026-07-28

ELISIO™-HX

Applicant Nipro Medical Corporation

K-Number K261399

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QXM 2026-07-28

Revi System

Applicant Bluewind Medical , Ltd.

K-Number K253651

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HRS 2026-07-28

Xpert Ankle

Applicant Newclip Technics

K-Number K261511

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QDQ 2026-07-28

See-Mode Augmented Reporting Tool, Breast (SMART-B)

Applicant See-Mode Technologies Pty, Ltd.

K-Number K260303

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