Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

NKB 2023-04-19

Altus Spine Monaco Pedicle Screw System

Applicant Altus Spine

K-Number K230766

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LON 2023-04-19

Selux AST System; Model AST Gen 1.0

Applicant Selux Diagnostics, Inc.

K-Number K211748

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QWF 2023-04-19

Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface

Applicant Medtronic, Inc.

K-Number K223168

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DWA 2023-04-18

Anivia SG1000 Pump Console

Applicant Apmtd, Inc.

K-Number K230698

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QEW 2023-04-18

ClotTriever BOLD Catheter

Applicant Inari Medical, Inc.

K-Number K230494

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OHV 2023-04-18

SofWave System

Applicant Sofwave Medical, Ltd.

K-Number K230820

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JDO 2023-04-18

OsteoCentric Integrated Hip Fastener System

Applicant OsteoCentric Technologies

K-Number K230764

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GZL 2023-04-18

SENSOSEEG Depth Electrodes

Applicant Sensomedical Labs, Ltd.

K-Number K213170

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ODP 2023-04-18

UniVy OsteoVy-Ti Cervical IBF System

Applicant Vy Spine, LLC

K-Number K223513

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GEI 2023-04-18

Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200

Applicant Deltronix Equipamentos Ltda

K-Number K223784

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DTQ 2023-04-18

Terumo Advanced Perfusion System 1

Applicant Terumo Cardiovascular Systems Corporation

K-Number K221895

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IYN 2023-04-17

X-CUBE 50, X-CUBE 60

Applicant Alpinion Medical Systems Co., Ltd.

K-Number K223564

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