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

PKL 2024-01-26

Disposable Hemostatic Clips

Applicant Zhejiang Soudon Medical Technology Co., Ltd.

K-Number K232450

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QNR 2024-01-26

CentriMag Acute Circulatory Support System

Applicant ABBOTT MEDICAL

K-Number K234118

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OWB 2024-01-26

Ziehm Solo FD

Applicant Ziehm Imaging GmbH

K-Number K234109

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LSL 2024-01-26

Aptima Neisseria gonorrhoeae Assay

Applicant Hologic, Inc.

K-Number K231329

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DXN 2024-01-26

Arm-type Fully Automatic Digital Blood Pressure Monitor

Applicant Joytech Healthcare Co. , Ltd.

K-Number K231303

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PLF 2024-01-26

Trigon Trigon HA Stand-Alone Wedge Fixation System

Applicant Nvision Biomedical Technologies

K-Number K234116

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IPF 2024-01-26

M-Wave

Applicant Zynex Medical, Inc.

K-Number K233485

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OLO 2024-01-26

ExactechGPS® System

Applicant Blue Ortho

K-Number K233299

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KIF 2024-01-26

One-Fil

Applicant Mediclus Co., Ltd.

K-Number K232182

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OUR 2024-01-26

iFuse Bedrock Granite® Implant System

Applicant SI-BONE, Inc.

K-Number K233508

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GEI 2024-01-25

FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)

Applicant Sutter Medizintechnik GmbH

K-Number K233425

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KWQ 2024-01-25

ADIRA Lateral Plate System

Applicant Globus Medical, Inc.

K-Number K233735

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