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

FDS 2025-10-31

GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100

Applicant Actuated Medical, Inc.

K-Number K251041

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KRD 2025-10-30

OBSIDIO™ Conformable Embolic (M0013972101010)

Applicant Boston Scientific Corporation

K-Number K253376

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DZE 2025-10-30

GEN5 and GEN5+ Dental Implant System

Applicant Paragon Implant Mfg., LLC

K-Number K251938

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QAI 2025-10-30

ellacor System with Micro-Coring Technology

Applicant Cytrellis Biosystems, Inc.

K-Number K252752

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KWT 2025-10-30

Tornier Humeral Reconstruction System Max (Tornier HRS Max)

Applicant Tornier, Inc.

K-Number K251686

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ESW 2025-10-30

HANAROSTENT Esophagus Upper (CCC)

Applicant M.I.Tech Co., Ltd.

K-Number K253327

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PLA 2025-10-30

Arctx Cool Catheter Set

Applicant Arctx Medical

K-Number K250632

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NRY 2025-10-30

Zoom System (Zoom 4S Catheter)

Applicant Imperative Care, Inc.

K-Number K252046

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FPA 2025-10-30

BD Alaris Pump Infusion Set

Applicant Carefusion (Bd)

K-Number K250325

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IRP 2025-10-30

AIR COMPRESSION BOOTS 1018195,1018196

Applicant Merchsource, LLC

K-Number K251531

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QOF 2025-10-30

Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)

Applicant Diasorin Molecular, LLC

K-Number K252387

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QIH 2025-10-30

AiORTA - Plan

Applicant ViTAA Medical Solutions, Inc.

K-Number K250337

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