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

BTO 2026-09-11

Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)

Applicant Vitaltec Corporation

K-Number K253063

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JOW 2026-09-11

Sequential Circulator (SC-4004-DL, SC-4008-DL)

Applicant Bio Compression Systems, Inc.

K-Number K261807

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MLO 2026-09-11

ZBPro Diagnostic (Version 2.0)

Applicant Zbeats, Inc.

K-Number K261580

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FRO 2026-09-11

SkinSmart Antimicrobial HydroGel

Applicant Magic Science Supply, LLC

K-Number K254041

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QOF 2026-09-11

FINDER Flu A&B/SARS-CoV-2 Test

Applicant Baebies, Inc.

K-Number K261837

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QPC 2026-09-11

PRIMED AAMI Level 3 Open Back Gowns

Applicant PRIMED Medical Products, Inc.

K-Number K262007

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MQV 2026-09-11

Mg OSTEOREVIVE™;Mg OSTEOCRETE™

Applicant Bone Solutions, Inc.

K-Number K262230

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KIF 2026-09-11

Vioseal X

Applicant Spident Co., Ltd.

K-Number K262050

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KGI 2026-09-11

BoneVue

Applicant Curvebeam AI / Curvebeam, LLC

K-Number K254072

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FET 2026-09-10

4K Camera Head OLYMPUS CH-S700-08-LB

Applicant Olympus Medical Systems Corp.

K-Number K262079

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HAW 2026-09-10

Geniant Cranial (Navigated Neurosurgical Positioning Robot)

Applicant Koh Young Technology, Inc.

K-Number K253856

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JWH 2026-09-10

EVOLUTION MPX™ Total Knee System

Applicant Suzhou Microport Orthorecon Co., Ltd.

K-Number K262293

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