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

QIH 2024-09-12

Constellation (CON-001)

Applicant Q Bio, Inc.

K-Number K241280

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JWH 2024-09-12

EXULT Knee Replacement System

Applicant Corentec Co., Ltd.

K-Number K242401

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DTZ 2024-09-12

Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2

Applicant Qura S.R.L

K-Number K231982

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LLZ 2024-09-12

Elucid PlaqueIQ

Applicant Elucid Bioimaging, Inc.

K-Number K241524

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DZE 2024-09-12

Surgikor Fixation One, Abutment Blanks and Abutments

Applicant Surgikor, LLC

K-Number K240803

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OOK 2024-09-12

CoolSculpting Elite System

Applicant Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics

K-Number K233732

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ITI 2024-09-12

Electric wheelchair (C001)

Applicant Zhejiang Hfizer Medical Equipment Co., Ltd.

K-Number K242136

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JFB 2024-09-12

N7-S

Applicant Nuga Medical Co., Ltd.

K-Number K240168

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IYN 2024-09-12

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)

Applicant Canon Medical Systems Corporation

K-Number K241582

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PDJ 2024-09-12

Hipro Glycosylated Hemoglobin (HbA1c) Test System

Applicant Shijiazhuang Hipro Biotechnology Co., Ltd.

K-Number K220999

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QJZ 2024-09-12

VitalFlow Set with Balance Biosurface

Applicant Medtronic, Inc.

K-Number K240880

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FRC 2024-09-12

3M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M

Applicant 3M Company

K-Number K241710

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